Effect of Vitamin D3 on Cardiovascular Risk Factors

Not Applicable

Completed

• Conditions: Hypertensive Disease; Deficiency of Vitamin D3
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D3

• Registration Number: NCT01501916
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

Brief Summary

The aim of this study is to investigate whether a supplementation of Vitamin D3 can be used to reduce atherosclerotic risk factors.

Detailed Description

It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 can lower blood pressure in mildly hypertensive subjects who are naive to antihypertensive medication, whether Vitamin D reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.

major outcomes:

- decrease of systolic blood pressure in the treatment group in comparison with the placebo group

Study Timeline

• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-12-27
• Study First Posted: 2011-12-30
• Study Start: 2012-12
• Primary Completion: 2013-04
• Study Completion: 2013-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• human volunteers with mild hypertension

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Exclusion Criteria

• use of antihypertensive medication
• use of vitamin d or calcium supplements
• known renal, inflammatory or malignant diseases
• hypercalcemia or hypercalciuria
• participation in other clinical studies
• use of tanning booths during the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
vitamin d	Vitamin D3	-

Primary Outcome Measures

Name	Time	Method
blood pressure	after 8 weeks of supplementation	major outcome variable is the decrease oy systolic blood pressure in the treatment group in comparison with the placebo group.