Supplementation With Vitamin D Improves Leptin Resistance
NCT00907270 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2009-05-22
Summary
Participants will be randomly assigned in one of two groups. Group A: oral supplementation with 4,000 IU of vitamin D (cholecalciferol). Group B: oral supplementation with 400 IU of vitamin D (cholecalciferol). Both treatments will be consumed daily for 6 months.
Outcomes will be evaluated at baseline, three and six months. Variables related to leptin resistance will be evaluated.
The main hypothesis is that vitamin D will diminish leptin resistance in overweight and obese women. If the hypothesis is confirmed, women will show a reduction in the Resting energy expenditure: serum Leptin ratio (REE: Leptin ratio), as well as a reduction of hunger, body weight, body and abdominal fat and an increase in resting energy expenditure.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Cholecalciferol
Cholecalciferol: 4,000 IU/day and 400 IU/day
Sponsors & Collaborators
-
Mexican National Institute of Public Health
lead OTHER_GOV
Principal Investigators
-
Mario Flores-Aldana, MsC · National Institute of public Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2010-05-31
- Completion
- 2010-05-31
Countries
- Mexico
Study Locations
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