Supplementation With Vitamin D Improves Leptin Resistance
Effect of Vitamin D Supplementation on Leptin Resistance, Hunger, Body Weight and Resting Energy Expenditure in Obese Women.
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2009
CompletedFirst Posted
Study publicly available on registry
May 22, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedMay 22, 2009
May 1, 2009
8 months
May 20, 2009
May 20, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of leptin resistance: (resting energy expenditure: leptin ratio) before and after (3 and 6 months) supplementation with vitamin D3 (cholecalciferol) 4,000 or 400 IU/day.
basal, third and sixth month
Secondary Outcomes (1)
Effect of vitamin D supplementation (25-OH-D): hunger, body weight, energy intake, resting energy expenditure, and body fat, improvement on low intensity chronic inflammation, SOCS-3 expression and JAK2/STAT3 signal.
Basal, third and sixth month
Study Arms (2)
Cholecalciferol: 400 IU/day
ACTIVE COMPARATORControl: (n=50) Each subject will be evaluated after supplementation during six months with Vitamin D (Cholecalciferol: 400 IU/day)
Cholecalciferol 4000 IU/day
EXPERIMENTALExperimental: (n=50) Each subject will be evaluated after supplementation during six months with Vitamin D
Interventions
Cholecalciferol: 4,000 IU/day and 400 IU/day
Eligibility Criteria
You may qualify if:
- BMI: 25-29.9
- Serum vitamin D levels: 20-80 nmol/L (25-OH-D)
You may not qualify if:
- Liver disease
- Kidney disease
- Diabetes mellitus
- Malignity
- Any kind of hormonal disorder
- Medication that modify hunger/satiety answer and those medications that alter -the glucose/insulin metabolism
- Subjects with diet treatment to lose weight
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Social Insurance
Cuernavaca, Morelos, 62450, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mario Flores-Aldana, MsC
National Institute of public Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
May 20, 2009
First Posted
May 22, 2009
Study Start
September 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
May 22, 2009
Record last verified: 2009-05