Treatment of Obesity With Vitamin D (40.000 IE Per Week for 1 Year)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Tromso
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Body Weight
Study Overview
Brief Summary
The purpose of the study is to evaluate if supplementation with vitamin D in doses of 20.000IU per week and 40.000 IU per week will result in weight loss in obese subjects as compared to placebo during 1 year.
Detailed Description
We will include 450 obese subjects that will be devided in 3 groups: 40.000IU cholecalciferol per week, 20.000 IU cholecalciferol per week, and placebo. All subjects will be given 500 mg calcium per day. There will be visits every tird month. In addition to weight reduction, we will also evaluate the calcium metabolism (blood test and urin samples), insulin sensitivity, muscle strenght, blood pressure and depression.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 21 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •BMI 30 - 40
- •serum calcium < 2.55 mmol/L
Exclusion Criteria
- •serious diseases
- •reduced kidney function
- •renal stone disease
- •using psychopharmaca
- •using drugs for weight reduction
Outcomes
Primary Outcomes
Body Weight
Body composition
Measures of calcium metabolism
Insulin sensitivity
Muscle strength
Depression score
Blood pressure
Secondary Outcomes
No secondary outcomes reported