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
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Summary
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EudraCT number |
2009-018125-70 |
Trial protocol |
AT |
Global end of trial date |
08 Feb 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
06 May 2020
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First version publication date |
06 May 2020
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Other versions |
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Summary report(s) |
RCT paper |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ENM-EA-016
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02136771 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Medical University of Graz
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Sponsor organisation address |
Auenbruggerplatz 15, Graz, Austria, 8036
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Public contact |
Stefan Pilz, Medical University of Graz, 0043 031638581143,
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Scientific contact |
Stefan Pilz, Medical University of Graz, 0043 031638581143,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
08 Feb 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
08 Feb 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Feb 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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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
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Protection of trial subjects |
Regular visits at our outpatient clinic including laboratory measurements
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Jun 2011
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Scientific research | ||
Long term follow-up duration |
10 Years | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 200
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Worldwide total number of subjects |
200
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EEA total number of subjects |
200
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
150
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From 65 to 84 years |
50
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85 years and over |
0
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Recruitment
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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. | |||||||||
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Pre-assignment
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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). | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
200 | |||||||||
Number of subjects completed |
200 | |||||||||
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Period 1
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Period 1 title |
Randomization phase (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Investigator, Subject | |||||||||
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
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | |||||||||
Arm description |
Oily drops as placebo | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Oleovit D3
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral drops
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Routes of administration |
Oral use
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Dosage and administration details |
7 drops daily
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Arm title
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Intervention | |||||||||
Arm description |
Vitamin D arm | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Oleovit D3
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral drops
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Routes of administration |
Oral use
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Dosage and administration details |
7 drops a day for 8 weeks
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Oily drops as placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Intervention
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Reporting group description |
Vitamin D arm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Oily drops as placebo | ||
Reporting group title |
Intervention
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Reporting group description |
Vitamin D arm | ||
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End point title |
24-hour systolic blood pressure | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
8 weeks
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Statistical analysis title |
ANCOVA | ||||||||||||
Statistical analysis description |
ANCOVA
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Comparison groups |
Placebo v Intervention
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Number of subjects included in analysis |
183
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
> 0.05 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Median difference (final values) | ||||||||||||
Point estimate |
50
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
2.5 | ||||||||||||
upper limit |
97.5 | ||||||||||||
Variability estimate |
Standard error of the mean
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Adverse events information [1]
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Timeframe for reporting adverse events |
During the active treatment period
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
Vitamin D Intervention
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Reporting group description |
- | ||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
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| 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 |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
