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    Clinical Trial Results:
    Repetitive blood donations and endurance sport performance: does iron supplementation limit the negative effects on hematological parameters?

    Summary
    EudraCT number
    		 2017-003406-40
    Trial protocol
    		 BE  
    Global end of trial date
    31 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Apr 2019
    First version publication date
    20 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RK2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Université catholique de Louvain
    Sponsor organisation address
    Place de l'Université 1, Louvain-La-Neuve, Belgium, 1348
    Public contact
    Louise Deldicque, Université catholique de Louvain, 0032 10474443, louise.deldicque@uclouvain.be
    Scientific contact
    Louise Deldicque, Université catholique de Louvain, 0032 10474443, louise.deldicque@uclouvain.be
    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
    01 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We propose to measure the impact of 3 blood donations, interspersed by 3 months, on blood parameters and on performance during a maximal incremental test and to see whether iron supplementation can limit or even reverse the negative effects of donations on blood parameters reflecting iron status.
    Protection of trial subjects
    * At the Rode Kruis Vlanderen, during the blood donation, numerous physicians were present in case of emergency. At the Faculty of Motor Science (Louvain-La-Neuve), during the exercise test, the hemoglobin mass measurement and the blood sample collection, there was always a physician present in case of emergency. * Plasma ferritin concentrations was checked before starting and during the whole study (1 week before iron supplementation and at day 2, 7, 14, 28 after the beginning of iron supplementation, day 28 being the last day of supplementation. Analyses were repeated at each iron supplementation following blood donation). If a value above 300μg/l ferritin would have been measured, iron supplementation would have been immediately stopped. * Exercise testing: a medical screening was performed before the beginning of the experiment to ensure that the participants were able to perform maximal exercise tests. In addition, participants were told that they can stop exercising at any time. A test was terminated if a subject shows any untoward signs and symptoms, including pallor, severe nausea and dizziness. * Subjects were asked to report every adverse events to the investigator until 2 months after the end of the trial and therefore the iron supplementation, even in case of premature clinical trial termination. Every adverse events reported by the subjects was recorded by the Principal investigator and the promotor. The physician evaluated the seriousness and the causality with the product and decided the action to take.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2017
    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
    Belgium: 44
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    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)
    44
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment between September 2017 and November 2017

    Pre-assignment
    Screening details
    		 Inclusion criteria: - age between 18-50 years - BMI between 20-28 kg/m2 - hours sport per week between 1-6 Screening of 50 subjects. 6 screening failure

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    * Blood donation: subjects were isolated from each other and were blinded using a sterile field so that theywere not be able to see their arm. Moreover, they listened to music through a headphone, . They were all stitched by a needle but no blood was collected for the control-control group * No information was added on the pill to allow subject to recognize iron or glucose supplementation

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo group
    Arm description
    		 - No blood donation - Glucose supplementation during 4 weeks following each blood donations for the other groups
    Arm type
    		 Placebo

    Investigational medicinal product name
    Glucose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    400mg/capsule, 1 capsule per day during 4 weeks following each blood donation

    Arm title
    		 Donation - placebo group
    Arm description
    		 - Blood donation (3 blood donations with three months of interval) - Glucose supplementation 4 weeks after each blood donations
    Arm type
    		 Placebo

    Investigational medicinal product name
    Glucose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    400mg/capsule, 1 capsule per day during 4 weeks following each blood donation

    Arm title
    		 Donation - 20mg iron group
    Arm description
    		 - Blood donation (three blood donations with three months of interval) - Iron supplementation: 173.72mg of ferrous gluconate per day during 4 weeks following each blood donation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Losferron 1/4
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Effervescent tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1/4 losferron tablet (173.72 mg of ferrous gluconate) per day during 4 weeks following each blood donation.

    Arm title
    		 Donation - 80mg iron group
    Arm description
    		 - Blood donation (three blood donations with three months of interval - iron supplementation : 695mg of ferrous gluconate per day during 4 weeks following each blood donation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Losferron
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Effervescent tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet of losferron per day (695mg of ferrous gluconate) during 4 weeks following each blood donation

    Number of subjects in period 1
    		Placebo group Donation - placebo group Donation - 20mg iron group Donation - 80mg iron group
    Started
    8
    12
    12
    12
    Completed
    7
    11
    11
    11
    Not completed
    1
    1
    1
    1
         Adverse event, non-fatal
    -
    1
    -
    -
         Lost to follow-up
    1
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo group
    Reporting group description
    		 - No blood donation - Glucose supplementation during 4 weeks following each blood donations for the other groups

    Reporting group title
    Donation - placebo group
    Reporting group description
    		 - Blood donation (3 blood donations with three months of interval) - Glucose supplementation 4 weeks after each blood donations

    Reporting group title
    Donation - 20mg iron group
    Reporting group description
    		 - Blood donation (three blood donations with three months of interval) - Iron supplementation: 173.72mg of ferrous gluconate per day during 4 weeks following each blood donation

    Reporting group title
    Donation - 80mg iron group
    Reporting group description
    		 - Blood donation (three blood donations with three months of interval - iron supplementation : 695mg of ferrous gluconate per day during 4 weeks following each blood donation

    Reporting group values
    		 Placebo group Donation - placebo group Donation - 20mg iron group Donation - 80mg iron group Total
    Number of subjects
    		 8 12 12 12 44
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 8 12 12 12 44
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 24.3 (18 to 32) 21.5 (18 to 33) 22.5 (19 to 33) 24 (19 to 31) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0 0 0
        Male
    		 8 12 12 12 44

    End points

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    End points reporting groups
    Reporting group title
    Placebo group
    Reporting group description
    		 - No blood donation - Glucose supplementation during 4 weeks following each blood donations for the other groups

    Reporting group title
    Donation - placebo group
    Reporting group description
    		 - Blood donation (3 blood donations with three months of interval) - Glucose supplementation 4 weeks after each blood donations

    Reporting group title
    Donation - 20mg iron group
    Reporting group description
    		 - Blood donation (three blood donations with three months of interval) - Iron supplementation: 173.72mg of ferrous gluconate per day during 4 weeks following each blood donation

    Reporting group title
    Donation - 80mg iron group
    Reporting group description
    		 - Blood donation (three blood donations with three months of interval - iron supplementation : 695mg of ferrous gluconate per day during 4 weeks following each blood donation

    Primary: peak oxygen consumption

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    End point title
    		 peak oxygen consumption
    End point description
    Measurement of this endpoint at several time points: - 1 week before first blood donation - 2 days after first blood donation - 1 week after first blood donation - 2 weeks after first blood donation - 4 weeks after first blood donation - 1 week before second blood donation - 2 days after second blood donation - 1 week after second blood donation - 2 weeks after second blood donation - 4 weeks after second blood donation - 1 week before third blood donation - 2 days after third blood donation - 1 week after third blood donation - 2 weeks after third blood donation - 4 weeks after third blood donation
    End point type
    Primary
    End point timeframe
    4 weeks after the third blood donation
    End point values
    		 Placebo group Donation - placebo group Donation - 20mg iron group Donation - 80mg iron group
    Number of subjects analysed
    5
    11
    11
    11
    Units: mL/min/kg
        arithmetic mean (standard error)
    56.4 ( 4.3 )
    48.6 ( 1.7 )
    47.4 ( 3.5 )
    53.5 ( 2.4 )
    Statistical analysis title
    		 mixed ANOVA model
    Statistical analysis description
    A mixed ANOVA model (SAS Statistical Software) was used with the subjects as a random variable and groups (placebo, donation alone, donation + 20mg iron and donation + 80mg iron) and condition (time) as fixed independent variables. Contrast analyses were performed to compare means, applying a Sidak correction. Statistical significance was set at p < 0.05
    Comparison groups
    Placebo group v Donation - placebo group v Donation - 20mg iron group v Donation - 80mg iron group
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Variability estimate
    Standard error of the mean

    Secondary: hemoglobin

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    End point title
    		 hemoglobin
    End point description
    Measurement of this endpoint at several time points: - 1 week before first blood donation - 2 days after first blood donation - 1 week after first blood donation - 2 weeks after first blood donation - 4 weeks after first blood donation - 1 week before second blood donation - 2 days after second blood donation - 1 week after second blood donation - 2 weeks after second blood donation - 4 weeks after second blood donation - 1 week before third blood donation - 2 days after third blood donation - 1 week after third blood donation - 2 weeks after third blood donation - 4 weeks after third blood donation
    End point type
    Secondary
    End point timeframe
    4 weeks after third blood donation
    End point values
    		 Placebo group Donation - placebo group Donation - 20mg iron group Donation - 80mg iron group
    Number of subjects analysed
    5
    11
    11
    11
    Units: g/dL
        arithmetic mean (standard error)
    14.6 ( 0.4 )
    14.5 ( 0.3 )
    14.4 ( 0.3 )
    14.1 ( 0.2 )
    Statistical analysis title
    		 mixed ANOVA model
    Comparison groups
    Placebo group v Donation - placebo group v Donation - 20mg iron group v Donation - 80mg iron group
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: red blood cells

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    End point title
    		 red blood cells
    End point description
    Measurement of this endpoint at several time points: - 1 week before first blood donation - 2 days after first blood donation - 1 week after first blood donation - 2 weeks after first blood donation - 4 weeks after first blood donation - 1 week before second blood donation - 2 days after second blood donation - 1 week after second blood donation - 2 weeks after second blood donation - 4 weeks after second blood donation - 1 week before third blood donation - 2 days after third blood donation - 1 week after third blood donation - 2 weeks after third blood donation - 4 weeks after third blood donation
    End point type
    Secondary
    End point timeframe
    4 weeks after third blood donation
    End point values
    		 Placebo group Donation - placebo group Donation - 20mg iron group Donation - 80mg iron group
    Number of subjects analysed
    5
    11
    11
    11
    Units: 10E12/L
        arithmetic mean (standard error)
    4.6 ( 0.1 )
    4.7 ( 0.1 )
    4.6 ( 0.1 )
    4.6 ( 0.1 )
    Statistical analysis title
    		 mixed ANOVA model
    Comparison groups
    Placebo group v Donation - placebo group v Donation - 20mg iron group v Donation - 80mg iron group
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Iron

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    End point title
    		 Iron
    End point description
    Measurement of this endpoint at several time points: - 1 week before first blood donation - 2 days after first blood donation - 1 week after first blood donation - 2 weeks after first blood donation - 4 weeks after first blood donation - 1 week before second blood donation - 2 days after second blood donation - 1 week after second blood donation - 2 weeks after second blood donation - 4 weeks after second blood donation - 1 week before third blood donation - 2 days after third blood donation - 1 week after third blood donation - 2 weeks after third blood donation - 4 weeks after third blood donation
    End point type
    Secondary
    End point timeframe
    4 weeks after third blood donation
    End point values
    		 Placebo group Donation - placebo group Donation - 20mg iron group Donation - 80mg iron group
    Number of subjects analysed
    5
    11
    11
    11
    Units: µg/dL
        arithmetic mean (standard error)
    102 ( 15 )
    85 ( 13 )
    97 ( 7 )
    116 ( 12 )
    Statistical analysis title
    		 mixed ANOVA model
    Comparison groups
    Placebo group v Donation - placebo group v Donation - 20mg iron group v Donation - 80mg iron group
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Transferrin

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    End point title
    		 Transferrin
    End point description
    Measurement of this endpoint at several time points: - 1 week before first blood donation - 2 days after first blood donation - 1 week after first blood donation - 2 weeks after first blood donation - 4 weeks after first blood donation - 1 week before second blood donation - 2 days after second blood donation - 1 week after second blood donation - 2 weeks after second blood donation - 4 weeks after second blood donation - 1 week before third blood donation - 2 days after third blood donation - 1 week after third blood donation - 2 weeks after third blood donation - 4 weeks after third blood donation
    End point type
    Secondary
    End point timeframe
    4 weeks after third blood donation
    End point values
    		 Placebo group Donation - placebo group Donation - 20mg iron group Donation - 80mg iron group
    Number of subjects analysed
    5
    11
    11
    11
    Units: g/L
        arithmetic mean (standard error)
    2.5 ( 0.03 )
    2.79 ( 0.09 )
    2.72 ( 0.09 )
    2.61 ( 0.09 )
    Statistical analysis title
    		 mixed ANOVA model
    Comparison groups
    Placebo group v Donation - placebo group v Donation - 20mg iron group v Donation - 80mg iron group
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Ferritin

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    End point title
    		 Ferritin
    End point description
    Measurement of this endpoint at several time points: - 1 week before first blood donation - 2 days after first blood donation - 1 week after first blood donation - 2 weeks after first blood donation - 4 weeks after first blood donation - 1 week before second blood donation - 2 days after second blood donation - 1 week after second blood donation - 2 weeks after second blood donation - 4 weeks after second blood donation - 1 week before third blood donation - 2 days after third blood donation - 1 week after third blood donation - 2 weeks after third blood donation - 4 weeks after third blood donation
    End point type
    Secondary
    End point timeframe
    4 weeks after third blood donation
    End point values
    		 Placebo group Donation - placebo group Donation - 20mg iron group Donation - 80mg iron group
    Number of subjects analysed
    5
    11
    11
    11
    Units: µg/L
        arithmetic mean (standard error)
    64 ( 8 )
    28 ( 9 )
    31 ( 4 )
    36 ( 6 )
    Statistical analysis title
    		 mixed ANOVA model
    Comparison groups
    Placebo group v Donation - placebo group v Donation - 20mg iron group v Donation - 80mg iron group
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Hepcidin

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    End point title
    		 Hepcidin
    End point description
    Measurement of this endpoint at several time points: - 1 week before first blood donation - 2 days after first blood donation - 1 week after first blood donation - 2 weeks after first blood donation - 4 weeks after first blood donation - 1 week before second blood donation - 2 days after second blood donation - 1 week after second blood donation - 2 weeks after second blood donation - 4 weeks after second blood donation - 1 week before third blood donation - 2 days after third blood donation - 1 week after third blood donation - 2 weeks after third blood donation - 4 weeks after third blood donation
    End point type
    Secondary
    End point timeframe
    4 weeks after third blood donation
    End point values
    		 Placebo group Donation - placebo group Donation - 20mg iron group Donation - 80mg iron group
    Number of subjects analysed
    5
    11
    11
    11
    Units: pg/mL
        arithmetic mean (standard error)
    18698 ( 6770 )
    3824 ( 1095 )
    7859 ( 2827 )
    7851 ( 2875 )
    Statistical analysis title
    		 mixed ANOVA model
    Comparison groups
    Placebo group v Donation - placebo group v Donation - 20mg iron group v Donation - 80mg iron group
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Eryhtropoietin

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    End point title
    		 Eryhtropoietin
    End point description
    Measurement of this endpoint at several time points: - 1 week before first blood donation - 2 days after first blood donation - 1 week after first blood donation - 2 weeks after first blood donation - 4 weeks after first blood donation - 1 week before second blood donation - 2 days after second blood donation - 1 week after second blood donation - 2 weeks after second blood donation - 4 weeks after second blood donation - 1 week before third blood donation - 2 days after third blood donation - 1 week after third blood donation - 2 weeks after third blood donation - 4 weeks after third blood donation
    End point type
    Secondary
    End point timeframe
    4 weeks after third blood donation
    End point values
    		 Placebo group Donation - placebo group Donation - 20mg iron group Donation - 80mg iron group
    Number of subjects analysed
    5
    11
    11
    11
    Units: mIU/mL
        arithmetic mean (standard error)
    8 ( 1.6 )
    10.8 ( 1.4 )
    7.4 ( 0.6 )
    9.9 ( 1.0 )
    Statistical analysis title
    		 mixed ANOVA model
    Comparison groups
    Placebo group v Donation - placebo group v Donation - 20mg iron group v Donation - 80mg iron group
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Soluble transferrin receptor

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    End point title
    		 Soluble transferrin receptor
    End point description
    Measurement of this endpoint at several time points: - 1 week before first blood donation - 2 days after first blood donation - 1 week after first blood donation - 2 weeks after first blood donation - 4 weeks after first blood donation - 1 week before second blood donation - 2 days after second blood donation - 1 week after second blood donation - 2 weeks after second blood donation - 4 weeks after second blood donation - 1 week before third blood donation - 2 days after third blood donation - 1 week after third blood donation - 2 weeks after third blood donation - 4 weeks after third blood donation
    End point type
    Secondary
    End point timeframe
    4 weeks after third blood donation
    End point values
    		 Placebo group Donation - placebo group Donation - 20mg iron group Donation - 80mg iron group
    Number of subjects analysed
    5
    11
    11
    11
    Units: mg/L
        arithmetic mean (standard error)
    2.15 ( 0.24 )
    2.72 ( 0.19 )
    2.24 ( 0.18 )
    2.18 ( 0.19 )
    Statistical analysis title
    		 mixed ANOVA model
    Comparison groups
    Placebo group v Donation - placebo group v Donation - 20mg iron group v Donation - 80mg iron group
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Hemoglobin mass

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    End point title
    		 Hemoglobin mass
    End point description
    Measurement of this endpoint at several time points: - 1 week before first blood donation - the day of the first blood donation - 2 days after first blood donation - 1 week after first blood donation - 2 weeks after first blood donation - 4 weeks after first blood donation - 1 week before second blood donation - the day of the second blood donation - 2 days after second blood donation - 1 week after second blood donation - 2 weeks after second blood donation - 4 weeks after second blood donation - 1 week before third blood donation - the day of the third blood donation - 2 days after third blood donation - 1 week after third blood donation - 2 weeks after third blood donation - 4 weeks after third blood donation
    End point type
    Secondary
    End point timeframe
    4 weeks after third blood donation
    End point values
    		 Placebo group Donation - placebo group Donation - 20mg iron group Donation - 80mg iron group
    Number of subjects analysed
    3
    5
    6
    5
    Units: g/kg
        arithmetic mean (standard error)
    13.59 ( 1.16 )
    12.22 ( 0.91 )
    12.36 ( 0.55 )
    12.75 ( 0.36 )
    Statistical analysis title
    		 mixed ANOVA model
    Comparison groups
    Placebo group v Donation - placebo group v Donation - 20mg iron group v Donation - 80mg iron group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Lactate max

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    End point title
    		 Lactate max
    End point description
    Measurement of this endpoint at several time points: - 1 week before first blood donation - 2 days after first blood donation - 1 week after first blood donation - 2 weeks after first blood donation - 4 weeks after first blood donation - 1 week before second blood donation - 2 days after second blood donation - 1 week after second blood donation - 2 weeks after second blood donation - 4 weeks after second blood donation - 1 week before third blood donation - 2 days after third blood donation - 1 week after third blood donation - 2 weeks after third blood donation - 4 weeks after third blood donation
    End point type
    Secondary
    End point timeframe
    4 weeks after thrid blood donation
    End point values
    		 Placebo group Donation - placebo group Donation - 20mg iron group Donation - 80mg iron group
    Number of subjects analysed
    5
    11
    11
    11
    Units: mM
        arithmetic mean (standard error)
    8.8 ( 1.5 )
    7.4 ( 1.1 )
    11.1 ( 1.1 )
    9.1 ( 0.9 )
    Statistical analysis title
    		 mixed ANOVA model
    Comparison groups
    Placebo group v Donation - placebo group v Donation - 20mg iron group v Donation - 80mg iron group
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Heart rate max

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    End point title
    		 Heart rate max
    End point description
    Measurement of this endpoint at several time points: - 1 week before first blood donation - 2 days after first blood donation - 1 week after first blood donation - 2 weeks after first blood donation - 4 weeks after first blood donation - 1 week before second blood donation - 2 days after second blood donation - 1 week after second blood donation - 2 weeks after second blood donation - 4 weeks after second blood donation - 1 week before third blood donation - 2 days after third blood donation - 1 week after third blood donation - 2 weeks after third blood donation - 4 weeks after third blood donation
    End point type
    Secondary
    End point timeframe
    4 weeks after third blood donation
    End point values
    		 Placebo group Donation - placebo group Donation - 20mg iron group Donation - 80mg iron group
    Number of subjects analysed
    5
    11
    11
    11
    Units: bpm
        arithmetic mean (standard error)
    180 ( 4 )
    184 ( 3 )
    191 ( 3 )
    180 ( 3 )
    Statistical analysis title
    		 mixed ANOVA model
    Comparison groups
    Placebo group v Donation - placebo group v Donation - 20mg iron group v Donation - 80mg iron group
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    - 1 week before blood donation - blood donation - 2 days fater blood donation - 1 week after blood donation - 2 weeks after blood donation - 4 weeks after blood donation Repeated at every 3 blood donations, interval 3 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Donation - 80mg iron group
    Reporting group description
    		 -

    Reporting group title
    Donation - placebo group
    Reporting group description
    		 -

    Reporting group title
    Placebo group
    Reporting group description
    		 -

    Reporting group title
    Donation - 20mg iron group
    Reporting group description
    		 -

    Serious adverse events
    		 Donation - 80mg iron group Donation - placebo group Placebo group Donation - 20mg iron group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Donation - 80mg iron group Donation - placebo group Placebo group Donation - 20mg iron group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 11 (18.18%)
    1 / 7 (14.29%)
    2 / 11 (18.18%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
         occurrences all number
    14
    1
    1
    0
    Constipation
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    0
    3
    Discomfort
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

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    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
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