Effects of Vitamin D Supplementation in Obesity

Phase 4

Completed

• Conditions: Vitamin D Deficiency; Obesity
• Interventions: Drug: Cholecalciferol; Drug: placebo

• Registration Number: NCT01037140
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Study Start: 2010-01
• Primary Completion: 2011-12
• Study Completion: 2012-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cholecalciferol	Cholecalciferol	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Effect on circulating inflammatory markers	6 months

Secondary Outcome Measures

Name	Time	Method
change in fat distribution	6 months
change in insulin sensitivity	6 months
change in bone mineral density	6 months
change in quality of life	6 months
change in depression score	6 months
change in muscle function	6 months
change in fat- and muscle metabolism	6 months

Trial Locations

Locations (1)

Dept. of Endocrinology and Metabolism, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark