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OpenTrials
Completed

NCT Number: NCT01501916

Effect of Vitamin D3 on Cardiovascular Risk Factors

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

daily dosage of 50 µg Vitamin D3 for 8 weeks

Other names: cholecalciferol

Placebo

Dietary Supplement

daily intake of placebo

Primary outcomes

  1. blood pressure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 30, 2011
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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