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    Clinical Trial Results:
    TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE USING FERROUS SULPHATE OR COSMOFER: TOLERANCE AND EFFECTS ON HAEMOGLOBIN, DISEASE ACTIVITY, MOOD, QUALITY OF LIFE AND AUTONOMIC NERVOUS SYSTEM ACTIVITY. AN OPEN LABEL PHASE IV NON-INFERIORITY STUDY.

    Summary
    EudraCT number
    2010-023797-39
    Trial protocol
    GB  
    Global end of trial date
    20 Aug 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Apr 2017
    First version publication date
    26 Apr 2017
    Other versions
    Summary report(s)
    End of Trial report
    Oral iron treatment response

    Trial information

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    Trial identification
    Sponsor protocol code
    v.2 21 July 2015
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01991314
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    CSP ref: 40738, EudraCT number: 2010-023797-39, REDA ref: 007495BLT, REC ref: 10/H0504/90
    Sponsors
    Sponsor organisation name
    Barts Health NHS Trust
    Sponsor organisation address
    Joint Research Management Office, QM Innovations Building, 5 Walden Street , London, United Kingdom, E12EF
    Public contact
    Marie-Claire Rickard, Joint Research Management Office, +44 2078827272, m.rickard@qmul.ac.uk
    Scientific contact
    Prof DS Rampton, Blizard Institute, +44 2035943500, d.rampton@qmul.ac.uk
    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
    09 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess these hypotheses: [1] there is no difference in the haemoglobin response to oral iron treatment of iron deficiency anaemia (IDA) in adolescent compared to adult IBD patients; [2] oral iron does not worsen disease activity in IBD; [3] response to oral iron is inversely related to serum hepcidin concentrations at baseline; and [4] treatment of anaemia improves QOL, mood and fatigue in adolescent and adult patients with IBD.
    Protection of trial subjects
    Patients were fully informed of the aims of the trial verbally and with patient information sheets. Their usual outpatient care was undertaken (including routine blood samples before and after treatment with oral iron), the only extra procedures being collection of two stool samples (for measurement of faecal calprotectin) and completion of psychometric questionnaires. There was no pain or distress involved.
    Background therapy
    Patients were on a range of treatments for their inflammatory bowel disease (IBD). These are shown in Table 1 of the attached paper and were, in adolescents and adults respectively, the following: 5 ASA 32 [71%], 17 [40%]; prednisolone/budesonide 7 [16%], 7 [16%]; enteral nutrition 3 [7%], 0 [0%]; thiopurine 23 [51%], 20 [47%]; methotrexate or ciclosporine 2 [4%], 0 [0%]; anti-TNF 2 [4%], 3 [7%]; antidepressants 0 [0%], 3 [7%].
    Evidence for comparator
    Iron deficiency anaemia [IDA] is a frequent complication of IBD. In children and adolescents IDA appears to be commoner than in adults and is often undertreated, perhaps reflecting paediatricians’ concerns about side effects, including worsening of disease activity, and about young people’s medication adherence. Quality of life [QOL] correlates negatively with severity of anaemia in IBD. Prospective studies of oral and intravenous iron in adults with IBD have shown improvements in QOL when the haemoglobin [Hb] is corrected but this effect has not been assessed in young people with IBD. Psychological distress and fatigue are common in people of all ages with IBD but to our knowledge there have been no prospective studies of the effects of oral iron supplementation on these factors in people with IBD. It is widely stated that the Hb response to oral iron is reduced in patients with active IBD: this has been confirmed in one but not all studies. Such an effect could be explained by involvement of hepcidin, which regulates iron homeostasis by inhibiting its uptake by enterocytes, macrophages and hepatocytes. Serum hepcidin levels are increased by pro-inflammatory cytokines; conversely, in iron deficiency, hepcidin levels fall. Serum hepcidin concentrations at baseline are related inversely to the Hb response to oral iron in patients with rheumatoid arthritis and other diseases, but whether this is true in IBD is unknown. We therefore undertook a prospective phase IV, open-label, parallel group, 6-week non-inferiority clinical trial using oral ferrous sulphate to assess the hypotheses that: [1] there is no difference in the Hb response to oral iron treatment of IDA in adolescent compared to adult IBD patients; [2] oral iron does not worsen disease activity in IBD; [3] response to oral iron is inversely to serum hepcidin concentrations at baseline; and [4] treatment of anaemia improves QOL, mood and fatigue in these patients
    Actual start date of recruitment
    04 Jan 2012
    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
    United Kingdom: 88
    Worldwide total number of subjects
    88
    EEA total number of subjects
    88
    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)
    41
    Adults (18-64 years)
    46
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Between January 2012 and April 2015, adolescent and adult patients with IBD (ulcerative colitis, Crohn's disease or IBD unclassified) were recruited at Barts and the Royal London Hospitals, Barts Health Trust or at Chelsea and Westminster Hospital, London , UK.

    Pre-assignment
    Screening details
    Patients who within the next month were due to attend the adult, young people's and paediatric IBD clinics were screened for the result of their haemoglobin concentration at their previous clinic attendance. Those found to be be anaemic were sent a letter of explanation about, and invitation to participate in the trial.

    Period 1
    Period 1 title
    Patients at baseline (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Adolescents aged 13-18 years
    Arm description
    Adolescents with IBD and IDA
    Arm type
    Active comparator

    Investigational medicinal product name
    Ferrous sulphate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg twice daily for 6 weeks

    Arm title
    Adults aged 19 or more
    Arm description
    Adults aged 19 or more with IBD and IDA
    Arm type
    Active comparator

    Investigational medicinal product name
    Ferrous sulphate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg twice daily for 6 weeks

    Number of subjects in period 1
    Adolescents aged 13-18 years Adults aged 19 or more
    Started
    45
    43
    Completed
    34
    32
    Not completed
    11
    11
         Adverse event, non-fatal
    5
    1
         Lost to follow-up
    6
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adolescents aged 13-18 years
    Reporting group description
    Adolescents with IBD and IDA

    Reporting group title
    Adults aged 19 or more
    Reporting group description
    Adults aged 19 or more with IBD and IDA

    Reporting group values
    Adolescents aged 13-18 years Adults aged 19 or more Total
    Number of subjects
    45 43 88
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    14.9 ± 1.67 32.5 ± 11.4 -
    Gender categorical
    Units: Subjects
        Female
    22 23 45
        Male
    23 20 43
    Haemoglobin
    Units: g/dl
        arithmetic mean (standard deviation)
    10.3 ± 1.21 10.9 ± 2.23 -
    Serum hepcidin
    Units: ng/ml
        arithmetic mean (standard deviation)
    31.3 ± 26.2 28.7 ± 19 -
    transferrin saturation
    Units: percent weight/weight
        arithmetic mean (standard deviation)
    7 ± 2.4 7.8 ± 3.9 -
    C-reactive protein
    Units: mg/l
        arithmetic mean (standard deviation)
    9.9 ± 22.8 11.4 ± 19 -
    Faecal calprotectin
    Units: ug/g
        arithmetic mean (standard deviation)
    295 ± 322 299 ± 511 -
    Shortened IBD Questionnaire
    Quality of life questionnaire validated for patients with IBD
    Units: numbers
        arithmetic mean (standard deviation)
    51 ± 12.7 44 ± 15.1 -
    HADS-A
    Hospital anxiety and depression score - anxiety
    Units: numbers
        arithmetic mean (standard deviation)
    7.3 ± 5.4 8.1 ± 4.6 -
    HADS-D
    HADS-depression
    Units: numbers
        arithmetic mean (standard deviation)
    4.4 ± 4 6 ± 3.9 -
    Perceived Stress Questionnaire-G
    Assessment of perceived stress
    Units: numbers
        arithmetic mean (standard deviation)
    57 ± 15.4 71 ± 15.7 -
    Multidimensional Fatigue Inventory
    Measure of fatigue
    Units: numbers
        arithmetic mean (standard deviation)
    58 ± 7.5 60 ± 7.2 -

    End points

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    End points reporting groups
    Reporting group title
    Adolescents aged 13-18 years
    Reporting group description
    Adolescents with IBD and IDA

    Reporting group title
    Adults aged 19 or more
    Reporting group description
    Adults aged 19 or more with IBD and IDA

    Primary: Increase in haemoglobin concentration (1)

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    End point title
    Increase in haemoglobin concentration (1)
    End point description
    Intention to treat analysis
    End point type
    Primary
    End point timeframe
    after 6 weeks on ferrous sulphate
    End point values
    Adolescents aged 13-18 years Adults aged 19 or more
    Number of subjects analysed
    45
    43
    Units: g/dl
        arithmetic mean (confidence interval 95%)
    1.22 (0.79 to 1.64)
    1.3 (0.84 to 1.75)
    Statistical analysis title
    ANCOVA
    Statistical analysis description
    To test the hypothesis of non-inferiority with maximal statistical power, ANCOVA was used to compare the change in mean haemoglobin levels between adults and adolescents after accounting for necessary covariates. 95% confidence intervals were established for the treatment effects to determine the status of the primary hypothesis.
    Comparison groups
    Adolescents aged 13-18 years v Adults aged 19 or more
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    = 0.8
    Method
    ANCOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.79
         upper limit
    -
    Variability estimate
    Standard deviation
    Dispersion value
    0.7

    Primary: Increase in haemoglobin concentration (2)

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    End point title
    Increase in haemoglobin concentration (2)
    End point description
    End point type
    Primary
    End point timeframe
    6 weeks
    End point values
    Adolescents aged 13-18 years Adults aged 19 or more
    Number of subjects analysed
    45
    43
    Units: g/dl
        arithmetic mean (standard deviation)
    1.4 ± 1.5
    1 ± 1.5
    Statistical analysis title
    Student's t test (unpaired)
    Statistical analysis description
    To compare the change in Hb produced by oral iron between the adolescent and adult groups
    Comparison groups
    Adolescents aged 13-18 years v Adults aged 19 or more
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.23
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (net)
    Confidence interval
    Notes
    [1] - See above. Statistical Package for the Social Sciences [SPSS] [version 16] was used for the statistical analysis.

    Primary: Numbers of patients normalising haemoglobin

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    End point title
    Numbers of patients normalising haemoglobin
    End point description
    Using the chi-squared test, we compared the proportions of patients in each group in whom ferrous sulphate produced a normalisation of haemoglobin concentration by WHO criteria
    End point type
    Primary
    End point timeframe
    6 weeks
    End point values
    Adolescents aged 13-18 years Adults aged 19 or more
    Number of subjects analysed
    45
    43
    Units: numbers
        number (not applicable)
    13
    16
    Statistical analysis title
    Chi squared test
    Comparison groups
    Adolescents aged 13-18 years v Adults aged 19 or more
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5
    Method
    Chi-squared
    Confidence interval

    Secondary: Increase in serum hepcidin concentration

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    End point title
    Increase in serum hepcidin concentration
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    Adolescents aged 13-18 years Adults aged 19 or more
    Number of subjects analysed
    45
    43
    Units: ng/ml
        arithmetic mean (standard error)
    4.8 ± 2.4
    6.6 ± 2.6
    Statistical analysis title
    Unpaired Student's t test
    Comparison groups
    Adolescents aged 13-18 years v Adults aged 19 or more
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    = 0.6
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (net)
    Confidence interval
    Notes
    [2] - This test was to see if there was a difference in hepcidin resposne to oral iron between the two arms.

    Secondary: Increase in transferrin saturation

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    End point title
    Increase in transferrin saturation
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    Adolescents aged 13-18 years Adults aged 19 or more
    Number of subjects analysed
    45
    43
    Units: percentage
        arithmetic mean (standard error)
    10.5 ± 2.3
    10.7 ± 2.2
    Statistical analysis title
    Unpaired Student's t test
    Comparison groups
    Adolescents aged 13-18 years v Adults aged 19 or more
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.98
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (net)
    Confidence interval

    Secondary: Change in C reactive protein

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    End point title
    Change in C reactive protein
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    Adolescents aged 13-18 years Adults aged 19 or more
    Number of subjects analysed
    34
    32
    Units: mg/l
        arithmetic mean (standard error)
    0.5 ± 1.5
    1.5 ± 3.4
    Statistical analysis title
    Unpaired Student's t test
    Comparison groups
    Adolescents aged 13-18 years v Adults aged 19 or more
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.78
    Method
    t-test, 2-sided
    Confidence interval

    Secondary: Change in faecal calprotectin

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    End point title
    Change in faecal calprotectin
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    Adolescents aged 13-18 years Adults aged 19 or more
    Number of subjects analysed
    34
    32
    Units: ug/g
        arithmetic mean (standard error)
    -35 ± 38
    -40 ± 81
    Statistical analysis title
    Unpaired Student's t test
    Comparison groups
    Adolescents aged 13-18 years v Adults aged 19 or more
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.96
    Method
    t-test, 2-sided
    Confidence interval

    Secondary: Change in SIBDQ

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    End point title
    Change in SIBDQ
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    Adolescents aged 13-18 years Adults aged 19 or more
    Number of subjects analysed
    34
    32
    Units: numbers
        arithmetic mean (standard error)
    3.2 ± 2.6
    5.7 ± 2
    Statistical analysis title
    Unpaired Student's t test
    Comparison groups
    Adolescents aged 13-18 years v Adults aged 19 or more
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.49
    Method
    t-test, 2-sided
    Confidence interval

    Secondary: Change in HADS-A

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    End point title
    Change in HADS-A
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    Adolescents aged 13-18 years Adults aged 19 or more
    Number of subjects analysed
    34
    32
    Units: numbers
        arithmetic mean (standard error)
    -0.7 ± 0.5
    -1.1 ± 0.7
    Statistical analysis title
    Unpaired Student's t test
    Comparison groups
    Adolescents aged 13-18 years v Adults aged 19 or more
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.85
    Method
    t-test, 2-sided
    Confidence interval

    Secondary: Change in HADS-D

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    End point title
    Change in HADS-D
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    Adolescents aged 13-18 years Adults aged 19 or more
    Number of subjects analysed
    34
    32
    Units: numbers
        arithmetic mean (standard error)
    -0.5 ± 0.5
    -0.9 ± 0.7
    Statistical analysis title
    Unpaired Student's t test
    Comparison groups
    Adolescents aged 13-18 years v Adults aged 19 or more
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.62
    Method
    t-test, 2-sided
    Confidence interval

    Secondary: Change in PSQ-G

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    End point title
    Change in PSQ-G
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    Adolescents aged 13-18 years Adults aged 19 or more
    Number of subjects analysed
    34
    32
    Units: numbers
        arithmetic mean (standard error)
    4.1 ± 2.5
    -11.8 ± 2.5
    Statistical analysis title
    Unpaired Student's t test
    Comparison groups
    Adolescents aged 13-18 years v Adults aged 19 or more
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    t-test, 2-sided
    Confidence interval

    Secondary: Change in MFI

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    End point title
    Change in MFI
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    Adolescents aged 13-18 years Adults aged 19 or more
    Number of subjects analysed
    34
    32
    Units: numbers
        arithmetic mean (standard error)
    0.9 ± 1.4
    1.9 ± 0.7
    Statistical analysis title
    Unpaired Student's t test
    Comparison groups
    Adolescents aged 13-18 years v Adults aged 19 or more
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.69
    Method
    t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 weeks
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    SNOMED CT
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Adolescents
    Reporting group description
    Adolescents aged 13-18

    Reporting group title
    Adults aged 19 or more
    Reporting group description
    -

    Serious adverse events
    Adolescents Adults aged 19 or more
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 43 (2.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Abdominal pain
    Additional description: Also vomiting and constipation
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ulcerative
    Additional description: Relapse of her ulcerative colitis as her steroid dose was reduced
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    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
    Adolescents Adults aged 19 or more
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 45 (17.78%)
    7 / 43 (16.28%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 45 (8.89%)
    4 / 43 (9.30%)
         occurrences all number
    4
    4
    Nausea
    Additional description: with vomiting
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Apr 2012
    Because of staffing reductions, we reduced the numbers of investigations (nutritional assessment, exercise tolerance testing and Neuroscope testing) which we had planned in the original version of the Protocol; in addition, we decided that we were no longer able to provide Cosmofer in the necessary time-frame for the patients who proved to be intolerant of oral ferrous sulphate.
    14 Sep 2012
    1. We requested an increase in the number of patients to be approached for recruitment from 90 to 140, because a higher than expected number of patients had turned out not to meet the inclusion criteria at the time of planned recruitment because their post-consent blood test showed them either to be no longer anaemic by WHO standards, or no longer iron deficient (Fe saturation <18%) (ie, during the time between their previous out-patient appointment and the intended recruitment date, their haemoglobin and iron status had improved). 2. Because of Pharmacy staffing shortages, to save time and inconvenience for patients attending afternoon clinics at the Royal London or any clinics at St Bartholomew’s Hospital, we arranged for prescriptions for ferrous sulphate to be collected from the Pharmacy at the Royal London by one of the investigators before the potential participants attended the clinic to give their written consent, giving them their tablets if/when this was been obtained.
    21 Jan 2013
    Change of name of sponsor from Barts and the London NHS Trust to Barts Health NHS Trust
    24 Jan 2013
    Because the initial suppliers, Wockhardt Ltd, could no longer make or supply ferrous sulphate tablets, we had to obtain them from an alternative supplier, Teva UK Ltd.
    10 Oct 2013
    1. Because of staff changes, we altered the arrangements for obtaining and countersigning patients' consent. Consent was taken by suitably trained (including GCP training) medically qualified and delegated staff at each site. At each site the consent form was countersigned by the site PI. 2. We changed our protocol to record that we were storing stool and serum samples at -40 rather than -80 degrees C. 3. As recruitment was going more slowly than initially hoped, we requested an extension of the duration of the study beyond 31 Dec 2013.
    15 Jul 2015
    1. We minimally changed the inclusion criteria so that iron deficiency was defined now by a transferrin saturation of <18% rather than <16%. We had noticed at a monitoring visit at Chelsea and Westminster Hospital that they were using a version of the protocol showing 16% rather than 18%. 2. The faecal calprotectin assays were to be done in the routine Barts Health NHS Trust immunology laboratory rather than at Kings College Hospital (as originally planned) because the assay had now been established here as a routine clinical test. 3. The hepcidin assays were now to be undertaken in the Gastroenterology Laboratory at the University of Birmingham, under the supervision of Dr Tariq Iqbal, rather than here, because the Birmingham assay was well-established and probably the most reliable in the UK. 4. The letter to patients' GPs about their recruitment was very minimally modified.

    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.
    For a description of the study's limitations, see the penultimate paragraph of the Discussion in the attached publication in Journal of Crohn's and Colitis, as well as Section 13 of the attached textual End of Trial Report.

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/27932449
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