Supplementation With Vitamin D Improves Leptin Resistance

May 20, 2009 updated by: Mexican National Institute of Public Health

Effect of Vitamin D Supplementation on Leptin Resistance, Hunger, Body Weight and Resting Energy Expenditure in Obese Women.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mario Flores-Aldana, MsC
  • Phone Number: 7451 (52)777-329-30-00
  • Email: mflores@insp.mx

Study Contact Backup

  • Name: Nayeli Macías-Morales, MsC
  • Phone Number: 7451 (52)777-329-30-00
  • Email: nmacias@insp.mx

Study Locations

  • Mexico
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62450
        • National Institute of Social Insurance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cholecalciferol: 400 IU/day
Control: (n=50) Each subject will be evaluated after supplementation during six months with Vitamin D (Cholecalciferol: 400 IU/day)
Dietary supplement: Cholecalciferol
Cholecalciferol: 4,000 IU/day and 400 IU/day
Other Names:
  • Cholecalciferol supplementation (400 IU and 4000 IU)
Experimental: Cholecalciferol 4000 IU/day
Experimental: (n=50) Each subject will be evaluated after supplementation during six months with Vitamin D
Dietary supplement: Cholecalciferol
Cholecalciferol: 4,000 IU/day and 400 IU/day
Other Names:
  • Cholecalciferol supplementation (400 IU and 4000 IU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: basal, third and sixth month
basal, third and sixth month

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Basal, third and sixth month
Basal, third and sixth month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mexican National Institute of Public Health

Investigators

  • Principal Investigator: Mario Flores-Aldana, MsC, National Institute of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

May 1, 2010

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

May 20, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (Estimate)

May 22, 2009

Study Record Updates

Last Update Posted (Estimate)

May 22, 2009

Last Update Submitted That Met QC Criteria

May 20, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69770

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Cholecalciferol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe