Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers
1 other identifier
interventional
107
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2012
CompletedFirst Posted
Study publicly available on registry
October 22, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedApril 22, 2013
April 1, 2013
5 months
October 15, 2012
April 19, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
25-hydroxyvitamin D3
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 Outcomes (3)
atherosclerotic risk factors
after 12 weeks of supplementation
inflammation
after 12 weeks of supplementation
hyperlipidemia
after 12 weeks of supplementation
Study Arms (2)
Vitamin D3
EXPERIMENTALcholecalciferol 20 µg per day for 12 weeks
Placebo
NO INTERVENTIONPlacebo for 12 weeks
Interventions
daily dosage of 20 µg Vitamin D3 for 12 weeks
Eligibility Criteria
You may qualify if:
- healthy volunteers
- age between 18 and 70 years
- informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Naturwissenschaftliche Fakultät III
Halle, Saxony-Anhalt, 06120, Germany
Related Publications (1)
Lehmann U, Riedel A, Hirche F, Brandsch C, Girndt M, Ulrich C, Seibert E, Henning C, Glomb MA, Dierkes J, Stangl GI. Vitamin D3 supplementation: Response and predictors of vitamin D3 metabolites - A randomized controlled trial. Clin Nutr. 2016 Apr;35(2):351-358. doi: 10.1016/j.clnu.2015.04.021. Epub 2015 May 19.
PMID: 26037521DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gabriele I Stangl, Prof. Dr.
Institut für Agrar- und Ernährungswissenschaften
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 15, 2012
First Posted
October 22, 2012
Study Start
November 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
April 22, 2013
Record last verified: 2013-04