Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers

April 19, 2013 updated by: Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg

Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers - a Randomized Trail

The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day for 12 weeks can be used to normalize vitamin d-Status

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to normalize insufficient vitamin d status and reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen-Anhalt
      • Halle/Saale, Sachsen-Anhalt, Germany, 06120
        • Naturwissenschaftliche Fakultät III

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteers
  • age between 18 and 70 years
  • informed consent

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
  • pregnancy or lactating period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D3
cholecalciferol 20 µg per day for 12 weeks
Dietary supplement: Vitamin D3
daily dosage of 20 µg Vitamin D3 for 12 weeks
Other Names:
  • cholecalciferol
No Intervention: Placebo
Placebo for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
25-hydroxyvitamin D3
Time Frame: after 12 weeks of supplementation
major outcome variable is the increase of 25-hydroxyvitamin D3 in the treatment group in comparison with the placebo group
after 12 weeks of supplementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
atherosclerotic risk factors
Time Frame: after 12 weeks of supplementation
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 reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.
after 12 weeks of supplementation
inflammation
Time Frame: after 12 weeks of supplementation
It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce inflammation as an atherosclerotic risk factor
after 12 weeks of supplementation
hyperlipidemia
Time Frame: after 12 weeks of supplementation
It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce hyperlipidemia as an atherosclerotic risk factor
after 12 weeks of supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Study Director: Gabriele I Stangl, Prof. Dr., Institut für Agrar- und Ernährungswissenschaften

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

October 18, 2012

First Posted (Estimate)

October 22, 2012

Study Record Updates

Last Update Posted (Estimate)

April 22, 2013

Last Update Submitted That Met QC Criteria

April 19, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0315668

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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