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

Deficiency of Vitamin D3 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711905
• Other study ID #: 0315668
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: April 19, 2013
• Start date: November 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deficiency of Vitamin D3

Intervention

Dietary Supplement:
• Vitamin D3
daily dosage of 20 µg Vitamin D3 for 12 weeks

Locations

Country	Name	City	State
Germany	Naturwissenschaftliche Fakultät III	Halle/Saale	Sachsen-Anhalt

Sponsors (2)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	atherosclerotic risk factors	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	Yes
Secondary	inflammation	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	Yes
Secondary	hyperlipidemia	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	Yes