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    Clinical Trial Results:
    Styrian Vitamin D Hypertension Trial: A randomized, double-blind, placebo controlled trial to study the effects of vitamin D supplementation on systolic blood pressure in vitamin D deficient hypertensive patients

    Summary
    EudraCT number
    		 2009-018125-70
    Trial protocol
    		 AT  
    Global end of trial date
    08 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 May 2020
    First version publication date
    06 May 2020
    Other versions
    Summary report(s)
    		 RCT paper

    Trial information

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    Trial identification
    Sponsor protocol code
    ENM-EA-016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02136771
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz
    Sponsor organisation address
    Auenbruggerplatz 15, Graz, Austria, 8036
    Public contact
    Stefan Pilz, Medical University of Graz, 0043 031638581143,
    Scientific contact
    Stefan Pilz, Medical University of Graz, 0043 031638581143,
    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
    08 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate in a randomized, double-blind, placebo controlled trial whether vitamin D supplementation significantly alters mean systolic ambulatory blood pressure
    Protection of trial subjects
    Regular visits at our outpatient clinic including laboratory measurements
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jun 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 10 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 200
    Worldwide total number of subjects
    200
    EEA total number of subjects
    200
    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)
    150
    From 65 to 84 years
    50
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from the outpatient clinics at the Department of Cardiology and the Department of Internal Medicine, Division of Endocrinology and Metabolism, Medical University of Graz, Austria. Patients were informed about the Styrian Vitamin D Hypertension Trial either by a conversation in the outpatient clinic or by telephone.

    Pre-assignment
    Screening details
    		 Eligible study participants were adults aged ≥18 years with arterial hypertension and a 25(OH)D serum concentration below 30 ng/mL (multiply by 2.496 to convert ng/mL to nmol/L).

    Pre-assignment period milestones
    Number of subjects started
    		 200
    Number of subjects completed
    		 200

    Period 1
    Period 1 title
    Randomization phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Randomization procedures were conducted using a web-based software (http://www.randomizer.at/) with good clinical practice compliance as confirmed by the Austrian Agency for Health and Food Safety. Eligible study participants were randomly allocated in a 1:1 ratio to receive 2800 IU vitamin D3 as 7 oily drops per day (Oleovit D3, producer: Fresenius Kabi Austria, A-8055 Graz, Austria; 1 bottle contains 180000 IU vitamin D3 in 12.5 mL) or otherwise a matching placebo as 7 oily drops per day

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Oily drops as placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Oleovit D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    7 drops daily

    Arm title
    		 Intervention
    Arm description
    		 Vitamin D arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oleovit D3
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    7 drops a day for 8 weeks

    Number of subjects in period 1
    		Placebo Intervention
    Started
    100
    100
    Completed
    100
    100

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Oily drops as placebo

    Reporting group title
    Intervention
    Reporting group description
    		 Vitamin D arm

    Reporting group values
    		 Placebo Intervention Total
    Number of subjects
    		 100 100 200
    Age categorical
    Age plus/minus standard deviation for the overall cohort was 60.0 plus/minus 11.1 years
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 75 75 150
        From 65-84 years
    		 25 25 50
        85 years and over
    		 0 0 0
    Age continuous
    mean age was 60.0 years plus/minus 11.1 years
    Units: years
        arithmetic mean (standard deviation)
    		 59.7 ± 11.4 60.5 ± 10.9 -
    Gender categorical
    Overall 47% females 53% males
    Units: Subjects
        Female
    		 48 46 94
        Male
    		 52 54 106

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Oily drops as placebo

    Reporting group title
    Intervention
    Reporting group description
    		 Vitamin D arm

    Primary: 24-hour systolic blood pressure

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    End point title
    		 24-hour systolic blood pressure
    End point description
    End point type
    Primary
    End point timeframe
    8 weeks
    End point values
    		 Placebo Intervention
    Number of subjects analysed
    92
    91
    Units: mm Hg
        arithmetic mean (standard deviation)
    131.6 ± 9.8
    131.4 ± 12.4
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA
    Comparison groups
    Placebo v Intervention
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (final values)
    Point estimate
    50
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.5
         upper limit
    		 97.5
    Variability estimate
    Standard error of the mean

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the active treatment period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Vitamin D Intervention
    Reporting group description
    		 -

    Reporting group title
    Placebo
    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: There were no non-serious events recorded
    Serious adverse events
    		 Vitamin D Intervention Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 100 (6.00%)
    4 / 100 (4.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    hospitalisation
         subjects affected / exposed
    6 / 100 (6.00%)
    4 / 100 (4.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Vitamin D Intervention Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (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
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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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