MedTrace Logo

Effects of Vitamin D Supplementation in Obesity

NCT01037140 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2012-08-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cholecalciferol

oral cholecalciferol tablets of 175 micrograms daily for 6 months

DRUG

placebo

oral placebo tablets similar to active comparator

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Louise Wamberg, Dr. · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-12-31
Completion
2012-07-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01037140 on ClinicalTrials.gov