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    Clinical Trial Results:
    Vitamin D supplementation and male infertility: a randomized double blinded clinical trial

    Summary
    EudraCT number
    		 2010-024588-42
    Trial protocol
    		 DK  
    Global end of trial date
    26 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2022
    First version publication date
    29 Mar 2022
    Other versions
    Summary report(s)
    		 Final publication

    Trial information

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    Trial identification
    Sponsor protocol code
    2010124801
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dept. of Growth and Reproduction, Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, København Ø, Denmark, 2100
    Public contact
    MD, PhD, Niels Jørgensen , Dept. of Growth and Reproduction , blombergjensen@gmail.com
    Scientific contact
    MD, PhD, Niels Jørgensen , Dept. of Growth and Reproduction , +45 35459592, blombergjensen@gmail.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
    25 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate whether vitamin D supplementation to vitamin D deficient or insufficient men improves semen quality and male fertility
    Protection of trial subjects
    During intervention period trial subjects had the opportunity to contact the outpatient clinic, with questions or symptoms.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jan 2011
    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
    Denmark: 307
    Worldwide total number of subjects
    307
    EEA total number of subjects
    307
    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)
    307
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 1427 men were referred with male infertility and screened . Of these, 330 infertile men formed the study cohort: 1002 men did not meet all inclusion criteria or met an exclusion criterion, and 95 men were eligible but did not wish to participate. The main reasons for exclusion were high vitamin D status, comorbidities or azoospermia.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Vitamin D
    Arm description
    		 cholecalciferol
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cholecalciferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Infertile men were randomly assigned 1:1 to either placebo or an initial oral dose of 300,000 IU of cholecalciferol dissolved in oil, followed by receipt of tablets consisting of cholecalciferol 1400 IU and calcium 500 mg once daily for 150 days (Pfizer, Copenhagen, Denmark).

    Arm title
    		 placebo
    Arm description
    		 Placebo tbl
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    calcium 500 mg x 1 daily

    Number of subjects in period 1
    		Vitamin D placebo
    Started
    151
    156
    Completed
    133
    136
    Not completed
    18
    20
         Lost to follow-up
    18
    20

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Vitamin D
    Reporting group description
    		 cholecalciferol

    Reporting group title
    placebo
    Reporting group description
    		 Placebo tbl

    Primary: Differences in semen quality

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    End point title
    		 Differences in semen quality
    End point description
    End point type
    Primary
    End point timeframe
    150 days
    End point values
    		 Vitamin D placebo
    Number of subjects analysed
    136
    133
    Units: Number pr. million
        median (inter-quartile range (Q1-Q3))
    12.8 (3.4 to 32.3)
    13.3 (4.2 to 38.5)
    Statistical analysis title
    		 BIOSTATISTICAL ANALYSIS
    Comparison groups
    Vitamin D v placebo
    Number of subjects included in analysis
    269
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    January 2011 to January 2015
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 GCP
    Dictionary version
    1
    Reporting groups
    Reporting group title
    pancreatitis
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: please see attachment for details
    Serious adverse events
    		 pancreatitis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 307 (0.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    1 / 307 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 pancreatitis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 307 (0.00%)

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29126319
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    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.

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