Effect of Vitamin D3 on Cardiovascular Risk Factors

Hypertensive Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501916
• Other study ID #: 0315668A
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2018
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deficiency of Vitamin D3
• Hypertension
• Hypertensive Disease

Intervention

Dietary Supplement:
• Vitamin D3
daily dosage of 50 µg Vitamin D3 for 8 weeks
• Placebo
daily intake of placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg	German Federal Ministry of Education and Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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