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

Not Applicable

Completed

• Conditions: Deficiency of Vitamin D3
• Interventions: Dietary Supplement: Vitamin D3

• Registration Number: NCT01711905
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

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 Timeline

• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-18
• Study First Posted: 2012-10-22
• Study Start: 2012-11
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-19
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D3	Vitamin D3	cholecalciferol 20 µg per day for 12 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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

Trial Locations

Locations (1)

Naturwissenschaftliche Fakultät III; 🇩🇪 Halle/Saale, Sachsen-Anhalt, Germany