Effects of Vitamin D Supplementation in Obesity
|ClinicalTrials.gov Identifier: NCT01037140|
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : August 2, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency Obesity||Drug: Cholecalciferol Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Subject.|
|Study Start Date :||January 2010|
|Primary Completion Date :||December 2011|
|Study Completion Date :||July 2012|
|Active Comparator: cholecalciferol||
oral cholecalciferol tablets of 175 micrograms daily for 6 months
Other Name: vitamin D
|Placebo Comparator: placebo||
oral placebo tablets similar to active comparator
- Effect on circulating inflammatory markers [ Time Frame: 6 months ]
- change in fat distribution [ Time Frame: 6 months ]
- change in insulin sensitivity [ Time Frame: 6 months ]
- change in bone mineral density [ Time Frame: 6 months ]
- change in quality of life [ Time Frame: 6 months ]
- change in depression score [ Time Frame: 6 months ]
- change in muscle function [ Time Frame: 6 months ]
- change in fat- and muscle metabolism [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037140
|Dept. of Endocrinology and Metabolism, Aarhus University Hospital|
|Principal Investigator:||Louise Wamberg, Dr.||Aarhus University Hospital|