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

Sponsor
Martin-Luther-Universität Halle-Wittenberg (Other)
Overall Status
Completed
CT.gov ID
NCT01711905
Collaborator
German Federal Ministry of Education and Research (Other)
107
Enrollment
1
Location
2
Arms
5
Duration (Months)
21.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Vitamin D3
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers - a Randomized Trail
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 25-hydroxyvitamin D3 [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

    Secondary Outcome Measures

    1. atherosclerotic risk factors [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.

    2. inflammation [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

    3. hyperlipidemia [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Naturwissenschaftliche Fakultät III Halle/Saale Sachsen-Anhalt Germany 06120

    Sponsors and Collaborators

    • Martin-Luther-Universität Halle-Wittenberg
    • German Federal Ministry of Education and Research

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ulrike Lehmann, Principal Investigator, Martin-Luther-Universität Halle-Wittenberg
    ClinicalTrials.gov Identifier:
    NCT01711905
    Other Study ID Numbers:
    • 0315668
    First Posted:
    Oct 22, 2012
    Last Update Posted:
    Apr 22, 2013
    Last Verified:
    Apr 1, 2013
    Additional relevant MeSH terms:
    Vitamin D
    Cholecalciferol

    Study Results

    No Results Posted as of Apr 22, 2013