Supplementation With Vitamin D Improves Leptin Resistance
NCT ID: NCT00907270
Last Updated: 2009-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2009-09-30
2010-05-31
Brief Summary
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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.
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Detailed Description
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Variables related to leptin resistance like resting metabolic expenditure, hunger, body weight and human body fat will be assessed. Outcomes will include, glucose, insulin, C-reactive protein, inflammatory interleukins (IL-6 \& TNF-α) and non-inflammatory interleukins (IL-10 \& TGF-β-1).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cholecalciferol: 400 IU/day
Control: (n=50) Each subject will be evaluated after supplementation during six months with Vitamin D (Cholecalciferol: 400 IU/day)
Cholecalciferol
Cholecalciferol: 4,000 IU/day and 400 IU/day
Cholecalciferol 4000 IU/day
Experimental: (n=50) Each subject will be evaluated after supplementation during six months with Vitamin D
Cholecalciferol
Cholecalciferol: 4,000 IU/day and 400 IU/day
Interventions
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Cholecalciferol
Cholecalciferol: 4,000 IU/day and 400 IU/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Serum vitamin D levels: 20-80 nmol/L (25-OH-D)
Exclusion Criteria
* 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
45 Years
65 Years
FEMALE
No
Sponsors
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Mexican National Institute of Public Health
OTHER_GOV
Responsible Party
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National Institute of Public Health
Principal Investigators
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Mario Flores-Aldana, MsC
Role: PRINCIPAL_INVESTIGATOR
National Institute of public Health
Locations
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National Institute of Social Insurance
Cuernavaca, Morelos, Mexico
Countries
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Central Contacts
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Other Identifiers
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69770
Identifier Type: -
Identifier Source: org_study_id
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