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    Clinical Trial Results:
    EFFICACY, SAFETY, AND QUALITY OF LIFE OF A LONG-TERM HOME PARENTERAL NUTRITION REGIMEN WITH EITHER LIPIDEM® OR LIPOFUNDIN® MCT A MONO-CENTER, RANDOMIZED, DOUBLE BLIND STUDY

    Summary
    EudraCT number
    		 2005-001938-32
    Trial protocol
    		 DE  
    Global end of trial date
    15 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Mar 2021
    First version publication date
    07 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HC-G-H-0503
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00530738
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    B. Braun Melsungen AG, Division Hospital Care
    Sponsor organisation address
    Carl-Braun-Straße 1, Melsungen, Germany, 34212
    Public contact
    Medical Scientific Affairs Hospital Care / Clinical Development, B. Braun Melsungen AG, studies@bbraun.com
    Scientific contact
    Medical Scientific Affairs Hospital Care / Clinical Development, B. Braun Melsungen AG, studies@bbraun.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Proof non-inferiority of a home parenteral nutrition (HPN) regimen over 8 weeks prepared with a lipid emulsion containing fish-oil (FO) derived n-3 polyunsaturated fatty acids (Lipidem®) as compared to a conventional HPN regimen without FO with respect to nutritional efficacy.
    Protection of trial subjects
    Treated in routine home parenteral nutrition.
    Background therapy
    		 Investigational test and reference lipid emulsions were admixed to NuTRIflex® plus, a 2 chamber-bag containing amino acids and glucose. Additional components of parenteral nutrition, such as vitamins, trace elements and electrolytes were allowed to be applied according to the patient’s individual requirements.
    Evidence for comparator
    		 Test and reference lipid emulsion (Lipidem® and Lipofundin® MCT) are 20% lipid emulsions with the same energy content but different lipid composition. The test lipid emulsion provides long-chain triglycerides (LCT), medium-chain triglycerides (MCT) and n-3 polyunsaturated fatty acids (n-3 PUFA) in a ratio of 4:5:1 while the reference lipid emulsion contains LCT and MCT in a 1:1 ratio but no n-3 PUFA. This allows assessing the impact of parenteral n-3 PUFA supplementation while providing equal amounts of fatty acids.
    Actual start date of recruitment
    08 Feb 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    29
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient in: 08.02.2008 Last patient out: 15.01.2014 Patients were recruited from the ambulatory nutritional service at the department of general, visceral, vascular, and thoracic surgery at the University Hospital of the Charité Berlin. Male and female patients aged between 18 and 80 years with a need of long-term HPN for at least 8 weeks.

    Pre-assignment
    Screening details
    		 43 patients recruited from the ambulatory nutritional service at the University Hospital of the Charité Berlin were screened for eligibility according to inclusion and exclusion criteria. One of these patients was not eligible (triglycerides > 300 mg/dL). The remaining 42 patients were enrolled into the study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Randomisation (1:1 ratio) via randomisation list (permuted block design, prepared by statistician not involved in final data analysis). IP-labelling according to randomisation list (label content: patient random number + 20 % lipid emulsion).Eligible patients received an enrollment number corresponding to the random number. Emergency envelopes ensured individual patient unblinding if necessary. The study was kept blinded until blind review meeting and final closure of the study database

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test group
    Arm description
    		 Test group received HPN regimen prepared with the test lipid emulsion providing MCT/LCT/n-3 PUFA in a 5:4:1 ratio (Lipidem® 20%)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lipidem® 20%
    Investigational medicinal product code
    Other name
    Lipoplus
    Pharmaceutical forms
    Emulsion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mL Lipidem® 20% were added to a NuTRIflex®plus 2-chamber bag (1500 ml, 1190 kcal, containing amino acids and glucose). This all-in-one admixture was administered as continuous infusion overnight via a central venous catheter on 4 to 6 nights per week depending on individual caloric requirements (determined via indirect calorimetry or based on estimated needs of about 25 to 35 kcal/kg/day) in order to cover at least 70% of caloric needs.

    Arm title
    		 Control group
    Arm description
    		 Control group received an HPN regimen prepared using Lipofundin® MCT 20% providing MCT and LCT in a 1:1 ratio.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lipofundin® MCT 20%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mL Lipofundin® MCT 20% were added to a NuTRIflex®plus 2-chamber bag (1500 ml, 1190 kcal, containing amino acids and glucose). This all-in-one admixture was administered as continuous infusion overnight via a central venous catheter on 4 to 6 nights per week depending on individual caloric requirements (determined via indirect calorimetry or based on estimated needs of about 25 to 35 kcal/kg/day) in order to cover at least 70% of caloric needs.

    Number of subjects in period 1
    		Test group Control group
    Started
    21
    21
    Completed
    15
    18
    Not completed
    6
    3
         Consent withdrawn by subject
    2
    -
         Adverse event, serious, non-fatal
    4
    2
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test group
    Reporting group description
    		 Test group received HPN regimen prepared with the test lipid emulsion providing MCT/LCT/n-3 PUFA in a 5:4:1 ratio (Lipidem® 20%)

    Reporting group title
    Control group
    Reporting group description
    		 Control group received an HPN regimen prepared using Lipofundin® MCT 20% providing MCT and LCT in a 1:1 ratio.

    Reporting group values
    		 Test group Control group Total
    Number of subjects
    		 21 21 42
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 15 14 29
        From 65-84 years
    		 6 7 13
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.8 ( 15.1 ) 58.0 ( 13.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 9 16
        Male
    		 14 12 26
    Body mass index
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 21.4 ( 2.6 ) 20.8 ( 2.3 ) -

    End points

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    End points reporting groups
    Reporting group title
    Test group
    Reporting group description
    		 Test group received HPN regimen prepared with the test lipid emulsion providing MCT/LCT/n-3 PUFA in a 5:4:1 ratio (Lipidem® 20%)

    Reporting group title
    Control group
    Reporting group description
    		 Control group received an HPN regimen prepared using Lipofundin® MCT 20% providing MCT and LCT in a 1:1 ratio.

    Subject analysis set title
    Intent to treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients who received the treatment at least once. This population is identical to the safety population.

    Subject analysis set title
    Per protocol population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients who received the treatment at least once, were treated according to the protocol and a statement regarding the primary endpoint is possible. This population is identical to the full analysis set including all patients who received the treatment at least once and a statement regarding the primary endpoint is possible.

    Primary: Difference of bodymass index between baseline and 8 weeks of treatment

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    End point title
    		 Difference of bodymass index between baseline and 8 weeks of treatment
    End point description
    The values for body weight which served as basis for the calculation of the BMI are presented as secondary endpoint.
    End point type
    Primary
    End point timeframe
    Change of bodymass index after 8 weeks of treatment calculated based on bodymass index determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    15
    18
    Units: kg/m²
        arithmetic mean (standard deviation)
    1.253 ( 1.060 )
    0.628 ( 0.903 )
    Statistical analysis title
    		 Assessment of non-inferiority
    Statistical analysis description
    The primary efficacy endpoint (BMI change between Baseline and 8 weeks of treatment) was to be compared between groups using a parametric (t-statistic) one-sided 97.5% confidence interval for the treatment difference.
    Comparison groups
    Control group v Test group
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.0768
    Method
    		 t-test, 1-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.625
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -0.07
         upper limit
    		 -
    Notes
    [1] - Non-inferiority would be postulated if the lower bound of the confidence interval was above -1.1 kg/m² (non-inferiority margin). It was defined in the protocol, that the primary efficacy analysis would be performed within the per-protocol set of patients.

    Secondary: Fatty acid pattern - Erythrocytes - Arachidonic acid

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    End point title
    		 Fatty acid pattern - Erythrocytes - Arachidonic acid
    End point description
    End point type
    Secondary
    End point timeframe
    Change of AA content in erythrocytes after 8 weeks of treatment calculated based on the fatty acid pattern in erythrocytes determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    11
    9
    Units: percent
        arithmetic mean (standard deviation)
    -3.757 ( 2.230 )
    0.085 ( 2.176 )
    Statistical analysis title
    		 Treatment comparison - changes of AA - erythrocyte
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.93
         upper limit
    		 -1.76

    Secondary: Fatty acid pattern - Erythrocytes - Eicosapentaenoic acid

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    End point title
    		 Fatty acid pattern - Erythrocytes - Eicosapentaenoic acid
    End point description
    End point type
    Secondary
    End point timeframe
    Change of EPA content in erythrocytes after 8 weeks of treatment calculated based on the fatty acid pattern in erythrocytes determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    11
    9
    Units: percent
        arithmetic mean (standard deviation)
    2.184 ( 0.950 )
    0.067 ( 0.125 )
    Statistical analysis title
    		 Treatment comparison - changes of EPA -erythrocyes
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.44
         upper limit
    		 2.79

    Secondary: Inflammatory parameters - Interleukin-6

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    End point title
    		 Inflammatory parameters - Interleukin-6
    End point description
    End point type
    Secondary
    End point timeframe
    Change of IL-6 after 8 weeks of treatment calculated based on values determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    11
    10
    Units: ng/l
        arithmetic mean (standard deviation)
    3.673 ( 7.522 )
    -1.130 ( 2.956 )
    Statistical analysis title
    		 Treatment comparison - changes of IL-6
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 10.13

    Secondary: Inflammatory parameters - Interleukin 10

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    End point title
    		 Inflammatory parameters - Interleukin 10
    End point description
    End point type
    Secondary
    End point timeframe
    Change of IL-10 after 8 weeks of treatment, calculated based on values determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    11
    10
    Units: ng/l
        arithmetic mean (standard deviation)
    0.000 ( 0.000 )
    0.030 ( 0.095 )
    Statistical analysis title
    		 Treatment comparison - changes of IL-10
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.03

    Secondary: Inflammatory parameter - TNF-alpha

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    End point title
    		 Inflammatory parameter - TNF-alpha
    End point description
    End point type
    Secondary
    End point timeframe
    Change of TNF-alpha after 8 weeks od treatment calculated based on values determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    11
    10
    Units: ng/l
        arithmetic mean (standard deviation)
    -1.245 ( 3.788 )
    -2.160 ( 3.640 )
    Statistical analysis title
    		 Treatment comparison - changes of TNF-alpha
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.49
         upper limit
    		 4.32

    Secondary: Inflammatory parameters - CRP

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    End point title
    		 Inflammatory parameters - CRP
    End point description
    End point type
    Secondary
    End point timeframe
    Change of CRP after 8 weeks of treatment calculated based on values determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    14
    18
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.373 ( 1.346 )
    -0.232 ( 1.379 )
    Statistical analysis title
    		 Treatment comparison - changes of CRP
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.39
         upper limit
    		 1.6

    Secondary: Fatty acid pattern - Platelets - Arachidonic Acid

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    End point title
    		 Fatty acid pattern - Platelets - Arachidonic Acid
    End point description
    End point type
    Secondary
    End point timeframe
    Change of AA content in platelets after 8 weeks of treatment calculated based on the fatty acid pattern in platelets determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    11
    9
    Units: percent
        arithmetic mean (standard deviation)
    -3.181 ( 3.384 )
    -1.881 ( 1.189 )
    Statistical analysis title
    		 Treatment comparison - changes of AA- platelets
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.8
         upper limit
    		 1.2

    Secondary: Fatty acid pattern - Serum phospholipids - Arachidonic Acid

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    End point title
    		 Fatty acid pattern - Serum phospholipids - Arachidonic Acid
    End point description
    End point type
    Secondary
    End point timeframe
    Change of AA content in serum phospholipids after 8 weeks of treatment calculated based on the fatty acid pattern in serum phospholipids determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    11
    9
    Units: percent
        arithmetic mean (standard deviation)
    -2.703 ( 1.495 )
    -0.006 ( 1.315 )
    Statistical analysis title
    		 Treatment comparison - changes in AA - phospholipi
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.04
         upper limit
    		 -1.36

    Secondary: Fatty acid pattern - Platelets - Eicosapentaenoic acid

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    End point title
    		 Fatty acid pattern - Platelets - Eicosapentaenoic acid
    End point description
    End point type
    Secondary
    End point timeframe
    Change of EPA content in platelets after 8 weeks of treatment calculated based on the fatty acid pattern in platelets determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    11
    9
    Units: percent
        arithmetic mean (standard deviation)
    3.503 ( 1.927 )
    0.077 ( 0.220 )
    Statistical analysis title
    		 Treatment comparison - changes of EPA - platelets
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.06
         upper limit
    		 4.79

    Secondary: Fatty acid pattern - Serum phospholipids - Eicosapentaenoic acid

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    End point title
    		 Fatty acid pattern - Serum phospholipids - Eicosapentaenoic acid
    End point description
    End point type
    Secondary
    End point timeframe
    Change of EPA content in serum phospholipids after 8 weeks of treatment calculated based on the fatty acid pattern in serum phospholipids determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    11
    9
    Units: percent
        arithmetic mean (standard deviation)
    3.497 ( 1.372 )
    0.020 ( 0.358 )
    Statistical analysis title
    		 Treatment comparison - changes of EPA -phospholipi
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.49
         upper limit
    		 4.47

    Secondary: Fatty acid pattern - Erythrocytes - Docosahexaenoic acid

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    End point title
    		 Fatty acid pattern - Erythrocytes - Docosahexaenoic acid
    End point description
    End point type
    Secondary
    End point timeframe
    Change of DHA content in erythrocytes after 8 weeks of treatment calculated based on the fatty acid pattern in erythrocytes determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    11
    9
    Units: percent
        arithmetic mean (standard deviation)
    2.206 ( 1.267 )
    0.030 ( 1.111 )
    Statistical analysis title
    		 Treatment comparison - changes of DHA -erythrocyte
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 3.31

    Secondary: Fatty acid pattern - Platelets - Docosahexaenoic acid

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    End point title
    		 Fatty acid pattern - Platelets - Docosahexaenoic acid
    End point description
    End point type
    Secondary
    End point timeframe
    Change of DHA content in platelets after 8 weeks of treatment calculated based on the fatty acid pattern in platelets determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    11
    9
    Units: percent
        arithmetic mean (standard deviation)
    1.878 ( 0.675 )
    0.119 ( 0.256 )
    Statistical analysis title
    		 Treatment comparison - changes of DHA - platelets
    Comparison groups
    Control group v Test group
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.26
         upper limit
    		 2.26

    Secondary: Fatty acid pattern - Serum phospholipids - Docosahexaenoic acid

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    End point title
    		 Fatty acid pattern - Serum phospholipids - Docosahexaenoic acid
    End point description
    End point type
    Secondary
    End point timeframe
    Change of DHA content in serum phospholipids after 8 weeks of treatment calculated based on the fatty acid pattern in serum phospholipids determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    11
    9
    Units: percent
        arithmetic mean (standard deviation)
    2.698 ( 1.342 )
    0.074 ( 0.613 )
    Statistical analysis title
    		 Treatment comparison - changes of DHA -phospholipi
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 3.64

    Secondary: Bio impedance analysis – resistance

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    End point title
    		 Bio impedance analysis – resistance
    End point description
    End point type
    Secondary
    End point timeframe
    Change of resistance after 8 weeks of treatment calculated based on the resistance measured at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    12
    14
    Units: ohm
        arithmetic mean (standard deviation)
    -24.750 ( 37.816 )
    12.786 ( 42.320 )
    No statistical analyses for this end point

    Secondary: Bio impedance analysis – reactance

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    End point title
    		 Bio impedance analysis – reactance
    End point description
    End point type
    Secondary
    End point timeframe
    Change of reactance after 8 weeks of treatment calculated based on the reactance measured at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    12
    14
    Units: ohm
        arithmetic mean (standard deviation)
    -0.917 ( 7.501 )
    1.714 ( 8.534 )
    No statistical analyses for this end point

    Secondary: Bio impedance analysis – body cell mass

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    End point title
    		 Bio impedance analysis – body cell mass
    End point description
    End point type
    Secondary
    End point timeframe
    Change of body cell mass after 8 weeks of treatment calculated based on the body cell mass measured at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    12
    15
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    0.775 ( 1.342 )
    0.780 ( 1.882 )
    No statistical analyses for this end point

    Secondary: Resting energy expenditure determined via indirect calorimetry

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    End point title
    		 Resting energy expenditure determined via indirect calorimetry
    End point description
    End point type
    Secondary
    End point timeframe
    Change of resting energy expenditure (REE) after 8 weeks of treatment calculated based on the REE determined via indirect calorimetry at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    13
    Units: kcal/day
        arithmetic mean (standard deviation)
    85.2 ( 131.8 )
    10.0 ( 296.8 )
    No statistical analyses for this end point

    Secondary: Body weight

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    End point title
    		 Body weight
    End point description
    Change of body weight was not statistically analyzed. The values are solely presented since body weight served as the basis for calculation of the primary endpoint BMI
    End point type
    Secondary
    End point timeframe
    Change of body weight after 8 weeks of treatment calculated based on the body weight determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    15
    18
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    3.673 ( 3.128 )
    1.972 ( 2.896 )
    No statistical analyses for this end point

    Secondary: Quality of Life - Global Health Status

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    End point title
    		 Quality of Life - Global Health Status
    End point description
    End point type
    Secondary
    End point timeframe
    Change of QoL "global health status" after 8 weeks of treatment calculated based on the QoL "global health status" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    15
    Units: score
        arithmetic mean (standard deviation)
    5.83 ( 24.23 )
    9.44 ( 21.79 )
    Statistical analysis title
    		 Change of QoL "global health status"
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.85
         upper limit
    		 15.63

    Secondary: QoL - Functional Scale - cognitive functioning

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    End point title
    		 QoL - Functional Scale - cognitive functioning
    End point description
    End point type
    Secondary
    End point timeframe
    Change of functional scale "cognitive functioning" after 8 weeks of treatment calculated based on the function scale "cognitive functioning" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    15
    Units: score
        arithmetic mean (standard deviation)
    8.33 ( 25.15 )
    0.0 ( 32.12 )
    Statistical analysis title
    		 Change of functional scale "cognitive functioning"
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.66
         upper limit
    		 33.32

    Secondary: QoL - Functional Scale - emotional functioning

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    End point title
    		 QoL - Functional Scale - emotional functioning
    End point description
    End point type
    Secondary
    End point timeframe
    Change of functional scale "emotional functioning" after 8 weeks of treatment calculated based on the functional scale "emotional functioning" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    15
    Units: score
        arithmetic mean (standard deviation)
    4.17 ( 34.97 )
    -1.67 ( 26.20 )
    Statistical analysis title
    		 Change of functional scale "emotional functioning"
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.45
         upper limit
    		 31.12

    Secondary: QoL - Functional Scale - physical functioning

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    End point title
    		 QoL - Functional Scale - physical functioning
    End point description
    End point type
    Secondary
    End point timeframe
    Change of functional scale "physical functioning" after 8 weeks of treatment calculated based on the functional scale "physical functioning" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    15
    Units: score
        arithmetic mean (standard deviation)
    1.33 ( 15.65 )
    6.22 ( 9.58 )
    Statistical analysis title
    		 Change of functional scale "physical functioning"
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.29
         upper limit
    		 5.51

    Secondary: QoL - Functional Scale - role functioning

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    End point title
    		 QoL - Functional Scale - role functioning
    End point description
    End point type
    Secondary
    End point timeframe
    Change of functional scale "role functioning" after 8 weeks of treatment calculated based on the functional scale "role functioning" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    15
    Units: score
        arithmetic mean (standard deviation)
    15.00 ( 31.87 )
    7.78 ( 38.25 )
    Statistical analysis title
    		 Changes of functional scale "role functioning"
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.08
         upper limit
    		 37.53

    Secondary: QoL - Functional Scale - social functioning

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    End point title
    		 QoL - Functional Scale - social functioning
    End point description
    End point type
    Secondary
    End point timeframe
    Change of functional scale "social functioning" after 8 weeks of treatment calculated based on the functional scale "social functioning" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    15
    Units: score
        arithmetic mean (standard deviation)
    10.00 ( 23.83 )
    13.33 ( 29.68 )
    Statistical analysis title
    		 Changes of functional scale "social functioning"
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.59
         upper limit
    		 19.92

    Secondary: QoL - Symptom Scale - appetite loss

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    End point title
    		 QoL - Symptom Scale - appetite loss
    End point description
    End point type
    Secondary
    End point timeframe
    Change of symptom scale "appetite loss" after 8 weeks of treatment calculated based on the symptom scale "appetite loss" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    15
    Units: score
        arithmetic mean (standard deviation)
    3.33 ( 24.60 )
    6.67 ( 33.81 )
    Statistical analysis title
    		 Change of symptom scale "appetite loss"
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.12
         upper limit
    		 22.45

    Secondary: QoL - Symptom Scale - constipation

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    End point title
    		 QoL - Symptom Scale - constipation
    End point description
    End point type
    Secondary
    End point timeframe
    Change of symptom scale "constipation" after 8 weeks of treatment calculated based on the symptom scale "constipation" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    9
    15
    Units: score
        arithmetic mean (standard deviation)
    -3.70 ( 11.11 )
    0.0 ( 0.0 )
    Statistical analysis title
    		 Changes of symptom scale "constipation"
    Comparison groups
    Control group v Test group
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.56
         upper limit
    		 2.16

    Secondary: QoL - Symptom Scale - diarhoea

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    End point title
    		 QoL - Symptom Scale - diarhoea
    End point description
    End point type
    Secondary
    End point timeframe
    Change of symptom scale "diarhoea" after 8 weeks of treatment calculated based on the symptom scale "diarhoea" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    8
    15
    Units: score
        arithmetic mean (standard deviation)
    -8.33 ( 23.57 )
    2.22 ( 29.46 )
    Statistical analysis title
    		 Changes of symptom scale "diarhoea"
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.72
         upper limit
    		 14.6

    Secondary: QoL - Symptom Scale - dyspnoea

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    End point title
    		 QoL - Symptom Scale - dyspnoea
    End point description
    End point type
    Secondary
    End point timeframe
    Change of symptom scale "dyspnoea" after 8 weeks of treatment calculated based on the symptom scale "dyspnoea" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    15
    Units: score
        arithmetic mean (standard deviation)
    -3.33 ( 10.54 )
    4.44 ( 27.79 )
    Statistical analysis title
    		 Changes of symptom scale "dyspnoea"
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.92
         upper limit
    		 11.36

    Secondary: QoL - Symptom Scale - fatigue

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    End point title
    		 QoL - Symptom Scale - fatigue
    End point description
    End point type
    Secondary
    End point timeframe
    Change of symptom scale "fatigue" after 8 weeks of treatment calculated based on the symptom scale "fatigue" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    15
    Units: score
        arithmetic mean (standard deviation)
    -10.00 ( 34.92 )
    -8.89 ( 23.46 )
    Statistical analysis title
    		 Changes of symptom scale "fatigue"
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.92
         upper limit
    		 11.36

    Secondary: QoL - Symptom Scale - financial problems

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    End point title
    		 QoL - Symptom Scale - financial problems
    End point description
    End point type
    Secondary
    End point timeframe
    Change of symptom scale "financial problems" after 8 weeks of treatment calculated based on the symptom scale "financial problems" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    15
    Units: score
        arithmetic mean (standard deviation)
    6.67 ( 21.08 )
    -2.22 ( 26.63 )
    Statistical analysis title
    		 Changes of symptom scale "financial problems"
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.89
         upper limit
    		 29.67

    Secondary: QoL - Symptom Scale - insomnia

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    End point title
    		 QoL - Symptom Scale - insomnia
    End point description
    End point type
    Secondary
    End point timeframe
    Change of symptom scale "insomnia" after 8 weeks of treatment calculated based on the symptom scale "insomnia" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    15
    Units: score
        arithmetic mean (standard deviation)
    -3.33 ( 39.91 )
    2.22 ( 29.46 )
    Statistical analysis title
    		 Changes of symptom scale "insomnia"
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34.21
         upper limit
    		 23.1

    Secondary: QoL - Symptom Scale - nausea / vomiting

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    End point title
    		 QoL - Symptom Scale - nausea / vomiting
    End point description
    End point type
    Secondary
    End point timeframe
    Change of symptom scale "nausea / vomiting" after 8 weeks of treatment calculated based on the symptom scale "nausea / vomiting" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    15
    Units: score
        arithmetic mean (standard deviation)
    3.33 ( 35.83 )
    -3.33 ( 19.11 )
    Statistical analysis title
    		 Changes of symptom scale "nausea/vomiting"
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.07
         upper limit
    		 29.4

    Secondary: QoL - Symptom Scale - pain

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    End point title
    		 QoL - Symptom Scale - pain
    End point description
    End point type
    Secondary
    End point timeframe
    Change of symptom scale "pain" after 8 weeks of treatment calculated based on the symptom scale "pain" determined at Baseline and after 8 weeks.
    End point values
    		 Test group Control group
    Number of subjects analysed
    10
    15
    Units: score
        arithmetic mean (standard deviation)
    -15.00 ( 19.95 )
    0.00 ( 19.92 )
    Statistical analysis title
    		 Changes of symptom scale "pain"
    Comparison groups
    Test group v Control group
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.83
         upper limit
    		 1.83

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    08Feb2008 - 15Jan2014
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Lipidem
    Reporting group description
    		 20% Lipid emulsion containing long-chain triglycerides (soya oil), medium-chain triglycerides and omega-3 fatty acid triglycerides in a 4:5:1 ratio

    Reporting group title
    Lipofundin
    Reporting group description
    		 20 % Lipid emulsion containaining long-chain triglyceride and medium-chain triglyceride in a 1:1 ratio (but no n-3 PUFA)

    Serious adverse events
    		 Lipidem Lipofundin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 21 (19.05%)
    4 / 21 (19.05%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Investigation
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Catheter placement
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Prerenal failure
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Device related sepsis
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Lipidem Lipofundin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 21 (52.38%)
    12 / 21 (57.14%)
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 21 (9.52%)
         occurrences all number
    2
    6
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Catheter site erythema
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Chills
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    3
    0
    Impaired healing
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    medical device complication
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    0
    10
    Nausea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    6
    0
    Vomiting
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 21 (4.76%)
         occurrences all number
    5
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    2
    Rash macular
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Skin haemorrhage
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Skin odour abnormal
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Stasis dermatitis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 21 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Bone pain
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 21 (14.29%)
         occurrences all number
    1
    6
    Neck pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 May 2007
    Sample Size: Sample Size was increased from 73 to 74 to ease randomization in two groups. Exclusion criteria: Acute necrotizing pancreatitis was added as exclusion criterion because it is a contraindication for the administration of Lipofundin® MCT, it.
    15 Nov 2007
    Inclusion criteria: Need for HPN had not to be newly diagnosed
    15 Apr 2008
    Exclusion criteria: Change of restrictions regarding lab values for fasting triglycerides and serum creatinine to allow inclusion of patients that would be normally treated with HPN including lipids Patient Information Form: Inclusion of travel reimbursement
    14 Jul 2008
    Secondary variables: Patients were supplied with weighing logs for the nutrition bags to document the amount of PN used. Magnetic Resonance Tomography (MRT) was set as optional measurement Study duration: Since start of study was delayed, duration of recruitment period was prolonged accordingly.
    15 Feb 2010
    Study duration: Prolongation of recruitment period from 24 months to 38 months.
    29 Nov 2010
    Exclusion criteria: Change of restrictions regarding lab values of platelet count: The limit was lowered to 120.000/mm3 Secondary variables: Physical examinations on V1 and V2 were removed Optional variable MRT was completely removed Serum insulin measurements were deleted (no routine laboratory value, not determined at any time). Deletion of additional analyses of blood samples (Free Fatty Acids (FFA), EPA, AA, Leukotrienes B4/B5 (LTB4/5), Thromboxane B2 (TxB2)) for newly recruited patients Patient Information Form / Informed Consent Form: The patient information was changed to reflect the changed protocol (mainly deletion of MRT) and included also minor editorial changes.
    20 Jul 2011
    Sample size: Re-evaluation of sample size resulting in reduced sample size of evaluable patients Label: Instead of stating batch number and expiry date of each IP on one label a code number was used on the label
    08 Oct 2012
    Sample size: Correction of estimated drop-out rate Study duration: Prolongation of recruitment period from 38 months to 70 months

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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