Supplementation With Vitamin D Improves Leptin Resistance

NCT ID: NCT00907270

Last Updated: 2009-05-22

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Study subjects will get dietary advice and physical activity counseling. At the end of the study, participants with suboptimal vitamin D levels (\<80 nmol/L 25-OH-D) will receive treatment to normalize their vitamin D status.

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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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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)

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

Cholecalciferol: 4,000 IU/day and 400 IU/day

Interventions

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Cholecalciferol

Cholecalciferol: 4,000 IU/day and 400 IU/day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cholecalciferol supplementation (400 IU and 4000 IU)

Eligibility Criteria

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Inclusion Criteria

* BMI: 25-29.9
* Serum vitamin D levels: 20-80 nmol/L (25-OH-D)

Exclusion Criteria

* 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mexican National Institute of Public Health

OTHER_GOV

Sponsor Role lead

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

Site Status

Countries

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Mexico

Central Contacts

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Mario Flores-Aldana, MsC

Role: CONTACT

(52)777-329-30-00 ext. 7451

Nayeli Macías-Morales, MsC

Role: CONTACT

(52)777-329-30-00 ext. 7451

Other Identifiers

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69770

Identifier Type: -

Identifier Source: org_study_id

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