Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers - a Randomized Trail
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- 25-hydroxyvitamin D3
Study Overview
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
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
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Placebo
Placebo for 12 weeks
Vitamin D3
cholecalciferol 20 µg per day for 12 weeks
Intervention: Vitamin D3 (Dietary Supplement)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- atherosclerotic risk factors(after 12 weeks of supplementation)
- inflammation(after 12 weeks of supplementation)
- hyperlipidemia(after 12 weeks of supplementation)
Investigators
Ulrike Lehmann
Principal Investigator
Martin-Luther-Universität Halle-Wittenberg