The Significance of Vitamin D Storage in Adipose Tissue

Phase 2

Withdrawn

• Conditions: Obesity
• Interventions: Drug: cholecalciferol; Drug: placebo

• Registration Number: NCT01728987
• Lead Sponsor: University of Tromso

Brief Summary

The study will examine the role of adipose tissue in vitamin D physiology, particularly its role as a depot. the study is randomized double blind and placebo controlled.

Detailed Description

vitamin d versus placebo will be given for 12 months. Biopsies will be taken at baseline and every 6 month for 2 years. Blood samples will be collected every 6th month. the study will thus give information on storage during vitamin d supplementation as well as use of vitamin d fat stores after stopping vitamin D supplementation

Study Timeline

• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-20
• Study Start: 2016-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15
• Primary Completion: 2018-12
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• healthy subjects

Exclusion Criteria

• hypercalcemia
• pregnancy
• women without safe contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cholecalciferol	cholecalciferol	vitamin d (cholecalciferol) will be given as a capsule of 20.000 Iu twice a week
placebo	placebo	the placebo capsules are looking identical to the vitamin d capsules and contain medium chain triglycerides and arachis oil

Primary Outcome Measures

Name	Time	Method
vitamin D in adipose tissue biopsies	12 months

Secondary Outcome Measures

Name	Time	Method
rate of decline of 25ohd in serum	12 months

Trial Locations

Locations (1)

University of Tromsø; 🇳🇴 Tromsø, Norway