The Significance of Vitamin D Storage in Adipose Tissue

Obesity Clinical Trial

Official title:

The Significance of Vitamin D Storage in Adipose Tissue

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01728987
• Other study ID #: TromsøEndo-2012-1
• Status: Withdrawn
• Phase: Phase 2
• First received: September 3, 2012
• Last updated: November 14, 2016
• Start date: August 2016
• Est. completion date: February 2019

Study information

• Verified date: November 2016
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• healthy subjects

Exclusion Criteria:

• hypercalcemia

• pregnancy

• women without safe contraception

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• cholecalciferol
as in arm description
• placebo
capsule looking identical to the cholecalciferol capsule

Locations

Country	Name	City	State
Norway	University of Tromsø	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vitamin D in adipose tissue biopsies		12 months	No
Secondary	rate of decline of 25ohd in serum		12 months	No