Effects of Vitamin D Supplementation in Obesity

Obesity Clinical Trial

Official title:

Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Subject.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037140
• Other study ID #: 2008-005581-31
• Status: Completed
• Phase: Phase 4
• First received: December 8, 2009
• Last updated: August 1, 2012
• Start date: January 2010
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

Obesity is an increasing health problem with numerous metabolic complications. Vitamin D deficiency is common in obesity, and in epidemiological studies vitamin D deficiency has been linked to metabolic complications, such as type 2 diabetes, insulin resistance and cardiovascular disease, as well as myopathy, osteoporosis and depression. In obesity, a low grade inflammation is present in the fat tissue, thereby releasing inflammatory molecules to the blood stream. In cell line studies as well as small clinical studies vitamin D has been shown to have the ability to reduce inflammation and cell growth.

In the present study the investigators wish to investigate the effect of vitamin D on fat-, muscle and bone metabolism. 30 healthy obese subjects will be treated with cholecalciferol 175 micrograms daily for 6 months and will be compared with 30 healthy obese subjects treated with placebo.

The investigators hypothesize that restoring vitamin D levels in vitamin D deficient obese subject will reduce inflammation and thereby reduce obesity-related complications.

The effect will be evaluated as follows:

• Levels of circulating inflammatory markers will be examined in blood samples collected prior to and after treatment.

• Effects on fat- and muscle metabolism will be evaluated in fat- and muscle samples taken before and after treatment.

• Effects on fat distribution will be evaluated by MRI scan before and after treatment.

• Effects on insulin sensitivity will be evaluated by hyperinsulinaemic euglycaemic clamp performed on a subgroup of subjects with impaired fasting glucose.

• Effects on bone marrow density will be evaluated by DEXA scans before and after treatment.

• Effects on quality of life and depression score will be evaluated by questionnaires used before and after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy obese (BMI 30 - 45 kg/m2)

• 25(OH) vitamin D < 50 nmol/l

Exclusion Criteria:

• Diabetes,

• Pregnancy or non-safe contraception,

• Vitamin D treatment within 3 months,

• Hypercalcaemia, renal failure,

• Liver failure, non eligibility for MRI-scan,

• Severe osteomalacia,

• Allergy towards study drug

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
oral cholecalciferol tablets of 175 micrograms daily for 6 months
• placebo
oral placebo tablets similar to active comparator

Locations

Country	Name	City	State
Denmark	Dept. of Endocrinology and Metabolism, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on circulating inflammatory markers		6 months	No
Secondary	change in fat distribution		6 months	No
Secondary	change in insulin sensitivity		6 months	No
Secondary	change in bone mineral density		6 months	No
Secondary	change in quality of life		6 months	No
Secondary	change in depression score		6 months	No
Secondary	change in muscle function		6 months	No
Secondary	change in fat- and muscle metabolism		6 months	No