Clinical trial NCT01037140: Effects of Vitamin D Supplementation in Obesity
Official title: Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Subject.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Obesity
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-12-21
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Effect on circulating inflammatory markers
timeFrame: 6 months
Secondary outcomes:
measure: change in fat distribution
timeFrame: 6 months
measure: change in insulin sensitivity
timeFrame: 6 months
measure: change in bone mineral density
timeFrame: 6 months
measure: change in quality of life
timeFrame: 6 months
measure: change in depression score
timeFrame: 6 months
measure: change in muscle function
timeFrame: 6 months
measure: change in fat- and muscle metabolism
timeFrame: 6 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dept. of Endocrinology and Metabolism, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Louise Wamberg, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bislev LS, Wamberg L, Rolighed L, Grove-Laugesen D, Rejnmark L. Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1317-1327. doi: 10.1210/clinem/dgac004.