Effect of Vitamin D3 on Cardiovascular Risk Factors

Effect of Vitamin D3 on Cardiovascular Risk Factors: a Randomized Trial in Human

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

Study Overview

• Status: Completed
• Conditions: Hypertensive Disease; Deficiency of Vitamin D3
• Intervention / Treatment: Dietary supplement: Vitamin D3; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• human volunteers with mild hypertension

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; daily intake of placebo
Experimental: vitamin d	Dietary supplement: Vitamin D3; daily dosage of 50 µg Vitamin D3 for 8 weeks; Other Names: cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	major outcome variable is the decrease oy systolic blood pressure in the treatment group in comparison with the placebo group.	after 8 weeks of supplementation

Collaborators and Investigators

• Sponsor: Martin-Luther-Universität Halle-Wittenberg
• Collaborators: German Federal Ministry of Education and Research

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: November 4, 2011
• First Submitted That Met QC Criteria: December 27, 2011
• First Posted (Estimate): December 30, 2011

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 0315668A