Effect of Vitamin D3 on Cardiovascular Risk Factors

This study has suspended participant recruitment.
(technical problems)
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT01501916
First received: November 4, 2011
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
Hypertensive Disease
Deficiency of Vitamin D3
Dietary Supplement: Vitamin D3
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D3 on Cardiovascular Risk Factors: a Randomized Trial in Human

Resource links provided by NLM:


Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • blood pressure [ Time Frame: after 8 weeks of supplementation ] [ Designated as safety issue: Yes ]
    major outcome variable is the decrease oy systolic blood pressure in the treatment group in comparison with the placebo group.


Estimated Enrollment: 250
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin d Dietary Supplement: Vitamin D3
daily dosage of 50 µg Vitamin D3 for 8 weeks
Other Name: cholecalciferol
Placebo Comparator: Placebo Dietary Supplement: Placebo
daily intake of placebo
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501916

Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
German Federal Ministry of Education and Research
Investigators
Study Director: Jutta Dierkes, Prof. Dr. Institut für Agrar- und Ernährungswissenschaften
  More Information

No publications provided

Responsible Party: Ulrike Lehmann, Principal Investigator, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01501916     History of Changes
Other Study ID Numbers: 0315668A
Study First Received: November 4, 2011
Last Updated: January 8, 2013
Health Authority: Germany: Federal Ministry of Education and Research

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 31, 2014