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Effect of Vitamin D3 on Cardiovascular Risk Factors

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ClinicalTrials.gov Identifier: NCT01501916
Recruitment Status : Suspended (technical problems)
First Posted : December 30, 2011
Last Update Posted : January 10, 2013
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Ulrike Lehmann, 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.

Condition or disease Intervention/treatment Phase
Hypertensive Disease Deficiency of Vitamin D3 Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D3 on Cardiovascular Risk Factors: a Randomized Trial in Human
Study Start Date : December 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ulrike Lehmann, Principal Investigator, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01501916     History of Changes
Other Study ID Numbers: 0315668A
First Posted: December 30, 2011    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

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