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    Clinical Trial Results:
    The effect of vitamin D supplementation on immune response following hepatitis B vaccine in incident and prevalent hemodialysis patients with vitamin D deficiency

    Summary
    EudraCT number
    		 2011-004621-26
    Trial protocol
    		 AT  
    Global end of trial date
    12 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Dec 2021
    First version publication date
    02 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Devitahep
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clinical Division of Nephrology
    Sponsor organisation address
    Auenbruggerplatz 27, Graz, Austria,
    Public contact
    Sabine Horn, Medical University Graz, 0043 31638512170, sabine.horn@medunigraz.at
    Scientific contact
    Sabine Horn, Medical University Graz, 0043 31638512170, sabine.horn@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
    15 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial is to evaluate whether vitamin D supplementation is able to ameliorate the response of vitamin D-deficient hemodialysis patients receiving hepatitis B immunization
    Protection of trial subjects
    Protection of Trial subjects was performed with clinical visits during their routinely performed hemodialysis sessions
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 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
    Austria: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    14
    From 65 to 84 years
    22
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from two dialysis units at the Clinical Division of Nephrology, Medical University of Graz, and the Department of Internal Medicine III (Nephrology and Dialysis), Feldkirch Academic Teaching Hospital. Patients were enrolled between October 4, 2012 and April 9, 2015.

    Pre-assignment
    Screening details
    		 A total of 37 patients were randomized, 20 allocated to the cholecalciferol supplementation group, 17 to the control group. Of these, 17 patients in the supplementation group and 11 in the control group completed the study and were analyzed per protocol (CONSORT 2010 flow diagram, Figure 1).

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Supplementation group
    Arm description
    		 Patients reveived 28000 IU cholecalciferol Weekly at the end of dialysis session to ensure adherence
    Arm type
    		 Experimental

    Investigational medicinal product name
    cholecalciferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    Patients reveived 28000 IU cholecalciferol Weekly at the end of dialysis session to ensure adherence

    Arm title
    		 Control group
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Supplementation group Control group
    Started
    20
    17
    Completed
    17
    11
    Not completed
    3
    6
         Adverse event, serious fatal
    1
    1
         Exclusion due of recovery of renal function
    -
    1
         Exclusion due to need for kidney transplantation
    -
    2
         kidney transplantation
    2
    -
         end of dialysis due to comorbidities
    -
    1
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 37 37
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 14 14
        From 65-84 years
    		 22 22
        85 years and over
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 26 26
    Subject analysis sets

    Subject analysis set title
    Anti-Hbs antibodies, Test group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Categorical data are presented as absolute and relative number of patients. For continuous data mean and standard deviation (SD) or median with interquartile range (1st quartile - 3rd quartile) is used, depending on its distribution. For correlation analysis we used Spearman's correlation coefficient. Categorical parameters were compared using exact Chi-squared tests, normally distributed continuous parameters were analysed with Student's T test and not normally distributed parameters with exact Mann-Whitney U test. A two-sided P value <0.05 was deemed to indicate statistical significance. All statistical analyses were performed with IBM SPSS Statistics 25 (Release 25.0.0.1 2017. Armonk (NY), USA).

    Subject analysis set title
    Anti-Hbs antibodies, Control group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Categorical data are presented as absolute and relative number of patients. For continuous data mean and standard deviation (SD) or median with interquartile range (1st quartile - 3rd quartile) is used, depending on its distribution. For correlation analysis we used Spearman's correlation coefficient. Categorical parameters were compared using exact Chi-squared tests, normally distributed continuous parameters were analysed with Student's T test and not normally distributed parameters with exact Mann-Whitney U test. A two-sided P value <0.05 was deemed to indicate statistical significance. All statistical analyses were performed with IBM SPSS Statistics 25 (Release 25.0.0.1 2017. Armonk (NY), USA).

    Subject analysis sets values
    		 Anti-Hbs antibodies, Test group Anti-Hbs antibodies, Control group
    Number of subjects
    17
    11
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    9
        From 65-84 years
    18
        85 years and over
    1
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    11
        Male
    26

    End points

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    End points reporting groups
    Reporting group title
    Supplementation group
    Reporting group description
    		 Patients reveived 28000 IU cholecalciferol Weekly at the end of dialysis session to ensure adherence

    Reporting group title
    Control group
    Reporting group description
    		 -

    Subject analysis set title
    Anti-Hbs antibodies, Test group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Categorical data are presented as absolute and relative number of patients. For continuous data mean and standard deviation (SD) or median with interquartile range (1st quartile - 3rd quartile) is used, depending on its distribution. For correlation analysis we used Spearman's correlation coefficient. Categorical parameters were compared using exact Chi-squared tests, normally distributed continuous parameters were analysed with Student's T test and not normally distributed parameters with exact Mann-Whitney U test. A two-sided P value <0.05 was deemed to indicate statistical significance. All statistical analyses were performed with IBM SPSS Statistics 25 (Release 25.0.0.1 2017. Armonk (NY), USA).

    Subject analysis set title
    Anti-Hbs antibodies, Control group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Categorical data are presented as absolute and relative number of patients. For continuous data mean and standard deviation (SD) or median with interquartile range (1st quartile - 3rd quartile) is used, depending on its distribution. For correlation analysis we used Spearman's correlation coefficient. Categorical parameters were compared using exact Chi-squared tests, normally distributed continuous parameters were analysed with Student's T test and not normally distributed parameters with exact Mann-Whitney U test. A two-sided P value <0.05 was deemed to indicate statistical significance. All statistical analyses were performed with IBM SPSS Statistics 25 (Release 25.0.0.1 2017. Armonk (NY), USA).

    Primary: number of patients with anti-HBs titer ≥10 IU/L

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    End point title
    		 number of patients with anti-HBs titer ≥10 IU/L
    End point description
    The primary endpoint was the number of patients with an anti-HBs titer ≥10 IU/L in the two groups. This endpoint was achieved by 35.3% of the patients in the supplementation group and 27.3% in the control group (p=0.704)
    End point type
    Primary
    End point timeframe
    The primary endpoint was the number of patients with an anti-HBs titer ≥10 IU/L in the two groups eight weeks after completing the vaccination course. The secondary endpoints were the number of patients with an anti-HBs titer >100 IU/L
    End point values
    		 Anti-Hbs antibodies, Test group Anti-Hbs antibodies, Control group
    Number of subjects analysed
    17
    11
    Units: Number of patients
    17
    11
    Statistical analysis title
    		 Effect of vitamin D supplementation
    Comparison groups
    Anti-Hbs antibodies, Test group v Anti-Hbs antibodies, Control group
    Number of subjects included in analysis
    28
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.704
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The timeframe for reporting adverse Event reporting was 24 hours
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Supplementation group
    Reporting group description
    		 Patients reveived 28000 IU cholecalciferol Weekly at the end of dialysis session to ensure adherence

    Reporting group title
    Control group
    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: Due to the critical patient population, it was defined that only adverse events with possible relation to the study medication/study procedures, and adverse events of special interest (hypercalcemia or hyperphosphatemia) have to be documented. Cholecalciferol supplementation was safe with no episode of hypercalcemia or hyperphosphatemia.
    Serious adverse events
    		 Supplementation group Control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Supplementation group Control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 17 (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.
    We used a standardized vaccination protocol with a recommended second-generation vaccine. The small number of patients completing the study is another limitation, and our trial is a pilot study.
    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.

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