Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Placebo controlled study on effects of vitamin D supplementation in type 1 diabetic subjects on immunological, endocrine and metabolic parameters: Step 2 of the Austrian Diabetes Prevention Programme (ADPP-002)

    Summary
    EudraCT number
    		 2010-018901-12
    Trial protocol
    		 AT  
    Global end of trial date
    27 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Aug 2021
    First version publication date
    06 Aug 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ADPP-002ENM-DA-017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01390480
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Diabetology, Austria
    Sponsor organisation address
    Auenbruggerplatz 15, Graz, Austria, 8036
    Public contact
    Co-investigator: Gerlies Treiber, Medical University of Graz, gerlies.treiber@medunigraz.at
    Scientific contact
    Principal Investigators: Thomas R. Pieber and Martin Borkenstein, Medical University of Graz, thomas.pieber@medunigraz.at
    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
    16 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate whether vitamin D supplementation significantly alters the proportion of circulating CD4+ T cells in subjects with type 1 diabetes (T1D)
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki and ICH Good Clinical Practice. All study participants were required to give written informed consent before any trial-related activities were initiated. Informed consent was either given by the participants or their guardians and in addition, assent from all children was obtained.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Nov 2010
    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
    Austria: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    11
    Adolescents (12-17 years)
    13
    Adults (18-64 years)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment was performed in three diabetes outpatient clinics in Austria (Graz, Vienna and Salzburg).

    Pre-assignment
    Screening details
    		 A total of 31 participants were screened and 30 were enrolled and randomly allocated in a 1:1 ratio to the treatment or placebo group. Out of these, 29 participants (treatment group n=14, placebo group n=15) completed the trial. Only the completers were included in the analysis.

    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, Carer
    Blinding implementation details
    The random allocation sequence was provided by staff with no other involvement in the trial. Unblinded trial staff ensured the correct treatment allocation and dispensing of trial products. Trial products were filled by an independent pharmacy and sent blinded to the study centres. They were visually identical, and were packed and labelled to fulfil the requirements for double-blind procedures.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment group
    Arm description
    		 The trial consisted of 14 visits (a baseline visit, study visits after 1, 3, 6, 9 and 12 months, a follow-up visit after 13 months and regular telephone visits in between). In the first month of treatment a loading dose of 140 IU cholecalciferol/kg body weight/day was administered to achieve serum vitamin D (25(OH)D) levels in the upper normal range. Oleovit D3 Tropfen (vitamin D drops, 400 IU/drop) was given orally once weekly. Compliance was assessed by phone contacts and the participant’s study diaries. 15 participants have been allocated to the treatment group. One participant of the treatment group was excluded after 3 months due to intentional additional intake of vitamin D supplementation and all data from this participant were excluded from analysis.
    Arm type
    		 Experimental

    Investigational medicinal product name
    OLEOVIT D3 Tropfen (Fresenius Kabi, Austria)
    Investigational medicinal product code
    10.989
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    Oleovit D3 drops, oral administration; 140 IU cholecalciferol/kg body weight/day in the first month followed by 70 IU cholecalciferol/kg body weight/day; the dose was weight-adjusted once weekly.

    Arm title
    		 Placebo group
    Arm description
    		 The trial consisted of 14 visits (a baseline visit, study visits after 1, 3, 6, 9 and 12 months, a follow-up visit after 13 months and regular telephone visits in between). Placebo (peanut oil) was given orally once weekly. Compliance was assessed by phone contacts and the participant’s study diaries.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    Peanut oil suspension, oral administration, amount equal to Oleovit D3 Tropfen.

    Number of subjects in period 1 [1]
    		Treatment group Placebo group
    Started
    14
    15
    Completed
    14
    15
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One participant of the treatment group was excluded after 3 months due to intentional additional intake of vitamin D supplementation and all data from this participant were excluded from analysis.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment group
    Reporting group description
    		 The trial consisted of 14 visits (a baseline visit, study visits after 1, 3, 6, 9 and 12 months, a follow-up visit after 13 months and regular telephone visits in between). In the first month of treatment a loading dose of 140 IU cholecalciferol/kg body weight/day was administered to achieve serum vitamin D (25(OH)D) levels in the upper normal range. Oleovit D3 Tropfen (vitamin D drops, 400 IU/drop) was given orally once weekly. Compliance was assessed by phone contacts and the participant’s study diaries. 15 participants have been allocated to the treatment group. One participant of the treatment group was excluded after 3 months due to intentional additional intake of vitamin D supplementation and all data from this participant were excluded from analysis.

    Reporting group title
    Placebo group
    Reporting group description
    		 The trial consisted of 14 visits (a baseline visit, study visits after 1, 3, 6, 9 and 12 months, a follow-up visit after 13 months and regular telephone visits in between). Placebo (peanut oil) was given orally once weekly. Compliance was assessed by phone contacts and the participant’s study diaries.

    Reporting group values
    		 Treatment group Placebo group Total
    Number of subjects
    		 14 15 29
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 5 5 10
        Adolescents (12-17 years)
    		 5 8 13
        Adults (18-64 years)
    		 4 2 6
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 12 (11.0 to 17.5) 13 (9.5 to 15.5) -
    Gender categorical
    Units: Subjects
        Female
    		 3 4 7
        Male
    		 11 11 22
    Body weight
    Units: kg
        arithmetic mean (standard deviation)
    		 52.2 ± 21.0 44.0 ± 14.4 -
    Body mass index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 19.2 ± 3.8 17.4 ± 2.1 -
    Diabetes duration
    Units: days
        arithmetic mean (standard deviation)
    		 61 ± 20 61 ± 28 -
    HbA1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 54.5 ± 11.6 63.5 ± 16.1 -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Treatment group
    Reporting group description
    		 The trial consisted of 14 visits (a baseline visit, study visits after 1, 3, 6, 9 and 12 months, a follow-up visit after 13 months and regular telephone visits in between). In the first month of treatment a loading dose of 140 IU cholecalciferol/kg body weight/day was administered to achieve serum vitamin D (25(OH)D) levels in the upper normal range. Oleovit D3 Tropfen (vitamin D drops, 400 IU/drop) was given orally once weekly. Compliance was assessed by phone contacts and the participant’s study diaries. 15 participants have been allocated to the treatment group. One participant of the treatment group was excluded after 3 months due to intentional additional intake of vitamin D supplementation and all data from this participant were excluded from analysis.

    Reporting group title
    Placebo group
    Reporting group description
    		 The trial consisted of 14 visits (a baseline visit, study visits after 1, 3, 6, 9 and 12 months, a follow-up visit after 13 months and regular telephone visits in between). Placebo (peanut oil) was given orally once weekly. Compliance was assessed by phone contacts and the participant’s study diaries.

    Primary: Changes in number and function of regulatory T cells

    		 Close Top of page
    End point title
    		 Changes in number and function of regulatory T cells
    End point description
    End point type
    Primary
    End point timeframe
    Months 0, 3, 6 and 12 of treatment
    End point values
    		 Treatment group Placebo group
    Number of subjects analysed
    14
    15
    Units: Percent
    arithmetic mean (standard deviation)
        Tregs in CD4, 0 months
    6.1 ± 1.9
    4.8 ± 1.7
        Tregs in CD4, 3 months
    5.6 ± 0.8
    5.1 ± 1.5
        Tregs in CD4, 6 months
    5.7 ± 1.4
    5.8 ± 1.8
        Tregs in CD4, 12 months
    5.8 ± 1.5
    5.4 ± 1.7
        Suppression of Teffs, 0 months
    -1.6 ± 25.6
    19.7 ± 26.7
        Suppression of Teffs, 3 months
    30.5 ± 39.4
    35.1 ± 23.3
        Suppression of Teffs, 6 months
    44.6 ± 23.8
    25.8 ± 24.8
        Suppression of Teffs, 12 months
    37.2 ± 25.0
    0.7 ± 28.9
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    Data were checked for normality by using Shapiro-Wilk test. Data that were not normally distributed were log transformed for analysis. Data were analysed with two-way repeated-measures ANOVA to determine changes over 12 months. Student’s t-test awas applied to compare differences between the groups. Mann-Whiney U-test was used for group comparisons if data deviated from normality. For the primary end point, the Bonferroni-Holm procedure was used to maintain an overall type 1 error rate of 5%.
    Comparison groups
    Treatment group v Placebo group
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: Effect on apoptosis of Tregs and Teffs

    		 Close Top of page
    End point title
    		 Effect on apoptosis of Tregs and Teffs
    End point description
    End point type
    Secondary
    End point timeframe
    Months 0, 3, 6 and 12 of treatment
    End point values
    		 Treatment group Placebo group
    Number of subjects analysed
    10
    6
    Units: Percent
    arithmetic mean (standard deviation)
        Apoptotic cells within Tregs, 0 months
    4.6 ± 4.9
    2.4 ± 2.7
        Apoptotic cells within Tregs, 3 months
    1.2 ± 1.7
    0.9 ± 0.8
        Apoptotic cells within Tregs, 6 months
    2.4 ± 1.8
    1.4 ± 0.6
        Apoptotic cells within Tregs, 12 months
    1.2 ± 0.7
    1.8 ± 0.7
        Apoptotic cells within Teffs, 0 months
    2.2 ± 1.5
    2.4 ± 2.6
        Apoptotic cells within Teffs, 3 months
    1.0 ± 0.9
    1.9 ± 1.3
        Apoptotic cells within Teffs, 6 months
    2.6 ± 1.8
    1.5 ± 1.6
        Apoptotic cells within Teffs, 12 months
    2.1 ± 1.2
    0.8 ± 0.4
    No statistical analyses for this end point

    Secondary: Effect on endogenous insulin production

    		 Close Top of page
    End point title
    		 Effect on endogenous insulin production
    End point description
    End point type
    Secondary
    End point timeframe
    Months 0, 6 and 12 of treatment
    End point values
    		 Treatment group Placebo group
    Number of subjects analysed
    13
    13
    Units: nmol/L
    arithmetic mean (standard deviation)
        Fasting C-peptide, 0 months
    0.20 ± 0.06
    0.21 ± 0.09
        Fasting C-peptide, 6 months
    0.18 ± 0.11
    0.15 ± 0.08
        Fasting C-peptide, 12 months
    0.20 ± 0.11
    0.12 ± 0.07
    No statistical analyses for this end point

    Secondary: Effect on HbA1c

    		 Close Top of page
    End point title
    		 Effect on HbA1c
    End point description
    End point type
    Secondary
    End point timeframe
    Months 0, 3, 6 and 12 of treatment
    End point values
    		 Treatment group Placebo group
    Number of subjects analysed
    14
    15
    Units: mmol/mol
    arithmetic mean (standard deviation)
        HbA1c, 0 months
    54.5 ± 11.6
    63.5 ± 16.1
        HbA1c, 3 months
    46.9 ± 10.2
    50.5 ± 12.4
        HbA1c, 6 months
    50.4 ± 15.0
    54.2 ± 17.7
        HbA1c, 12 months
    55.9 ± 16.2
    55.3 ± 12.3
    No statistical analyses for this end point

    Secondary: Effect on insulin requirement

    		 Close Top of page
    End point title
    		 Effect on insulin requirement
    End point description
    End point type
    Secondary
    End point timeframe
    Months 0, 3, 6 and 12 of treatment
    End point values
    		 Treatment group Placebo group
    Number of subjects analysed
    14
    15
    Units: IU/kg body weight/day
    arithmetic mean (standard deviation)
        Insulin, 0 months
    0.45 ± 0.19
    0.46 ± 0.22
        Insulin, 3 months
    0.37 ± 0.14
    0.39 ± 0.20
        Insulin, 6 months
    0.42 ± 0.23
    0.42 ± 0.22
        Insulin, 12 months
    0.45 ± 0.22
    0.64 ± 0.22
    No statistical analyses for this end point

    Secondary: Effect on serum 25(OH)D

    		 Close Top of page
    End point title
    		 Effect on serum 25(OH)D
    End point description
    End point type
    Secondary
    End point timeframe
    Months 0, 3, 6 and 12 of treatment
    End point values
    		 Treatment group Placebo group
    Number of subjects analysed
    14
    15
    Units: nmol/L
    arithmetic mean (standard deviation)
        Serum 25(OH)D, 0 months
    59.2 ± 20.0
    77.1 ± 39.9
        Serum 25(OH)D, 3 months
    159.5 ± 39.4
    82.1 ± 55.4
        Serum 25(OH)D, 6 months
    166.2 ± 28.2
    83.9 ± 30.2
        Serum 25(OH)D, 12 months
    154.0 ± 68.4
    80.1 ± 43.4
    No statistical analyses for this end point

    Secondary: Effect on serum calcium

    		 Close Top of page
    End point title
    		 Effect on serum calcium
    End point description
    End point type
    Secondary
    End point timeframe
    Months 0, 3, 6 and 12 of treatment
    End point values
    		 Treatment group Placebo group
    Number of subjects analysed
    14
    15
    Units: mmol/L
    arithmetic mean (standard deviation)
        Serum calcium, 0 months
    2.38 ± 0.10
    2.43 ± 0.07
        Serum calcium, 3 months
    2.40 ± 0.09
    2.42 ± 0.10
        Serum calcium, 6 months
    2.42 ± 0.11
    2.42 ± 0.09
        Serum calcium, 12 months
    2.42 ± 0.10
    2.43 ± 0.09
    No statistical analyses for this end point

    Secondary: Effect on serum parathormone

    		 Close Top of page
    End point title
    		 Effect on serum parathormone
    End point description
    End point type
    Secondary
    End point timeframe
    Months 0, 3, 6 and 12 of treatment
    End point values
    		 Treatment group Placebo group
    Number of subjects analysed
    6
    7
    Units: pg/mL
    arithmetic mean (standard deviation)
        Parathormone, 0 months
    37.7 ± 10.9
    39.1 ± 15.2
        Parathormone, 3 months
    26.8 ± 10.2
    34.6 ± 10.3
        Parathormone, 6 months
    32.6 ± 16.9
    46.9 ± 14.8
        Parathormone, 12 months
    33.9 ± 18.0
    42.0 ± 18.1
    No statistical analyses for this end point

    Secondary: Effect on urine calcium/creatinine ratio

    		 Close Top of page
    End point title
    		 Effect on urine calcium/creatinine ratio
    End point description
    End point type
    Secondary
    End point timeframe
    Months 0, 3, 6 and 12 of treatment
    End point values
    		 Treatment group Placebo group
    Number of subjects analysed
    14
    11
    Units: Ratio
    arithmetic mean (standard deviation)
        Urine calcium/creatinine ratio, 0 months
    0.20 ± 0.16
    0.29 ± 0.17
        Urine calcium/creatinine ratio, 3 months
    0.41 ± 0.37
    0.32 ± 0.24
        Urine calcium/creatinine ratio, 6 months
    0.40 ± 0.36
    0.30 ± 0.29
        Urine calcium/creatinine ratio, 12 months
    0.36 ± 0.28
    0.20 ± 0.13
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    All adverse events were collected from written informed consent up to the follow-up visit, regardless of seriousness or relationship to the trial products.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Treatment group
    Reporting group description
    		 -

    Reporting group title
    Placebo group
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment group Placebo group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 15 (13.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Insulin therapy
    Additional description: Hospitalisation due to initiation of an insulin pump
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treatment group Placebo group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 14 (50.00%)
    10 / 15 (66.67%)
    Injury, poisoning and procedural complications
    Ligament rupture
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Foot fracture
    Additional description: Broken metatarsal
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Fracture
    Additional description: Osseous tear fibula distal
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Skin abrasion
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Hand fracture
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Persistent depressive disorder
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Nephrocalcinosis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Endocrine disorders
    Insulin therapy
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Infections and infestations
    Gingivitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 15 (6.67%)
         occurrences all number
    2
    2
    Tonsillitis
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Otitis media
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    Respiratory tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Impetigo
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26277548
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 02:10:26 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA