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    Clinical Trial Results:
    Vitamin D supplementation in polymorphic light eruption: Randomized double-blinded placebo-controlled trial

    Summary
    EudraCT number
    		 2012-000300-15
    Trial protocol
    		 AT  
    Global end of trial date
    27 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Oct 2019
    First version publication date
    04 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VitD_PLE_2012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01595893
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz
    Sponsor organisation address
    Auenbruggerplatz 8, Graz, Austria, 8036
    Public contact
    Information Klinische Studie, Medical University of Graz, 43 316385 12538, dermatologie@medunigraz.at
    Scientific contact
    Information Klinische Studie, Medical University of Graz, Univ. Klinik Dermatologie, 43 316385 12538, dermatologie@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
    24 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 May 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine whether oral vitamin D supplementation abrogates the pathogenic mechanisms in PLE and prevents the manifestation of the disease.
    Protection of trial subjects
    The study did not contain any painful and stressful procedures and thus no specific measures had to be put in place to protect trial subjects, in particular for example measures to minimise pain and distress.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Mar 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: 26
    Worldwide total number of subjects
    26
    EEA total number of subjects
    26
    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)
    24
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place at the Medical University of Graz, Department of Dermatology. All patients provided written informed consent before starting any trial specific measures.

    Pre-assignment
    Screening details
    		 28 patients prescreened 26 patients screened and enrolled 10 patients had vitamin D levels < 30 ng/ml and thus qualified for the active study phase. One of these 10 patients dropped out before any active study procedure for personal reasons. Another patient had to be excluded due to high Parathormone Levels.

    Pre-assignment period milestones
    Number of subjects started
    		 28 [1]
    Number of subjects completed
    		 26

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 1
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Twenty-eight PLE patients were pre-screened and twenty-six patients (20 females and 6 males; mean age 46 years, range 24–76) were subjected to definite screening and first study visit between January and June of 2012 to 2014, before showing any manifestation of the disease in the season of enrolment. Two prescreened patients were not enrolled in the study. One patient was diagnosed with lupus erythematosus and one patient withdrew from the trial before any study procedure was done.
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Screening
    Arm description
    		 The clinical trial was prematurely terminated after 26 patients had been screened, since it became evident that the majority of patients had 25(OH)D serum levels above30 ng ml−1 and addressing the original study hypothesis (that oral vitamin D supplementation does protect against PLE) was neither reachable within a proper time frame nor appropriate and thus this analysis was not executed.
    Arm type
    		 Screening

    Investigational medicinal product name
    Vitamine D3
    Investigational medicinal product code
    Other name
    Oleovit D3
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    40,000 IE vitamin D3 per 70 kg body weight, given twice (2 weeks apart)

    Number of subjects in period 1
    		Screening
    Started
    26
    Completed
    26

    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
    		 26 26
    Age categorical
    28 patients prescreened 26 patients screened and enrolled 10 patients had vitamin D levels < 30 ng/ml and thus qualified for the active study phase One of these 10 patients dropped out before any active study procedure for personal reasons Another patient had to be excluded due to high Parathormone levels Thus, together, only 8 patients reached the active study phase: 5 received placebo 3 received Vitamin D
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Twenty-eight PLE patients were pre-screened and twenty-six patients (20 females and 6 males; mean age 46 years, range 24–76) were subjected to definite screening and first study visit between January and June of 2012 to 2014, before showing any manifestation of the disease in the season of enrolment.
    Units: years
        arithmetic mean (full range (min-max))
    		 46 (24 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 6 6
    Subject analysis sets

    Subject analysis set title
    Treg numbers
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The clinical trial was prematurely terminated after 26 patients had been screened, since it became evident that the majority of patients had 25(OH)D serum levels above 30 ng ml−1 and addressing the original study hypothesis (that oral vitamin D supplementation does protect against PLE) was neither reachable within a proper time frame nor appropriate and thus this analysis was not executed. The analysis of this report therefore focuses on investigating a possible influence of season on baseline Treg numbers, Treg function and vitamin D serum levels in 26 PLE patients at the time point of first study visit (TP1), taking place in the period spanning from January to June, whereas the other time points were omitted from the present analysis. Grouping of patients at TP1 in two periods, the winter period for those recruited from day 10 to 42 and the spring/early summer period for those recruited from day 108 to 176, allowed comparison of Treg numbers and function with respect to the season.

    Subject analysis sets values
    		 Treg numbers
    Number of subjects
    26
    Age categorical
    28 patients prescreened 26 patients screened and enrolled 10 patients had vitamin D levels < 30 ng/ml and thus qualified for the active study phase One of these 10 patients dropped out before any active study procedure for personal reasons Another patient had to be excluded due to high Parathormone levels Thus, together, only 8 patients reached the active study phase: 5 received placebo 3 received Vitamin D
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Twenty-eight PLE patients were pre-screened and twenty-six patients (20 females and 6 males; mean age 46 years, range 24–76) were subjected to definite screening and first study visit between January and June of 2012 to 2014, before showing any manifestation of the disease in the season of enrolment.
    Units: years
        arithmetic mean (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    20
        Male
    6

    End points

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    End points reporting groups
    Reporting group title
    Screening
    Reporting group description
    		 The clinical trial was prematurely terminated after 26 patients had been screened, since it became evident that the majority of patients had 25(OH)D serum levels above30 ng ml−1 and addressing the original study hypothesis (that oral vitamin D supplementation does protect against PLE) was neither reachable within a proper time frame nor appropriate and thus this analysis was not executed.

    Subject analysis set title
    Treg numbers
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The clinical trial was prematurely terminated after 26 patients had been screened, since it became evident that the majority of patients had 25(OH)D serum levels above 30 ng ml−1 and addressing the original study hypothesis (that oral vitamin D supplementation does protect against PLE) was neither reachable within a proper time frame nor appropriate and thus this analysis was not executed. The analysis of this report therefore focuses on investigating a possible influence of season on baseline Treg numbers, Treg function and vitamin D serum levels in 26 PLE patients at the time point of first study visit (TP1), taking place in the period spanning from January to June, whereas the other time points were omitted from the present analysis. Grouping of patients at TP1 in two periods, the winter period for those recruited from day 10 to 42 and the spring/early summer period for those recruited from day 108 to 176, allowed comparison of Treg numbers and function with respect to the season.

    Primary: Effect of Vitamin D to protect from clinical manifestation of PLE

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    End point title
    		 Effect of Vitamin D to protect from clinical manifestation of PLE [1]
    End point description
    None of the predefined end points were analysed since the recruitment rate was insufficient and the study was therefore prematurely terminated.
    End point type
    Primary
    End point timeframe
    within 144 hours
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The study was prematurely terminated. Predefined end points were not analysed.
    End point values
    		 Screening
    Number of subjects analysed
    26
    Units: Units on a score
    26
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    2012/04 - 2015/05/31
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    c
    Reporting groups
    Reporting group title
    Active study phase
    Reporting group description
    		 26 patients screened and enrolled 10 patients had vitamin D levels < 30 ng/ml and thus qualified for the active study Phase. One of these 10 patients dropped out before any active study procedure for personal reasons Another patient had to be excluded due to high Parathormone levels

    Serious adverse events
    		 Active study phase
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Active study phase
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    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: 26 patients screened and enrolled 10 patients had vitamin D levels < 30 ng/ml and thus qualified for the active study Phase. One of these 10 patients dropped out before any active study procedure for personal reasons Another patient had to be excluded due to high Parathormone Levels. The clinical trial was prematurely terminated after 26 patients had been screened. The majority of screened patients did not meet the main inclusion criterion which was a 25(OH)D serum level below 30 ng ml−1.

    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.
    The clinical trial was prematurely terminated after 26 patients had been screened, since it became evident that the majority of patients had 25(OH)D serum levels above 30 ng ml−1, addressing the study hypothesis was neither reachable nor appropriate

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26911519
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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
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