Dept. of Endocrinology and Metabolism, Aarhus University Hospital
Aarhus, Denmark
NCT Number: NCT01037140
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.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 4
Aarhus, Denmark
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
oral cholecalciferol tablets of 175 micrograms daily for 6 months
Other names: vitamin D
oral placebo tablets similar to active comparator
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
University of Aarhus
Other
Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Subject.
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