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Supplementation With Vitamin D Improves Leptin Resistance

Primary Purpose

Overweight, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
Mexican National Institute of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of Social Insurance

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cholecalciferol: 400 IU/day

Cholecalciferol 4000 IU/day

Arm Description

Control: (n=50) Each subject will be evaluated after supplementation during six months with Vitamin D (Cholecalciferol: 400 IU/day)

Experimental: (n=50) Each subject will be evaluated after supplementation during six months with Vitamin D

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 20, 2009
Last Updated
May 20, 2009
Sponsor
Mexican National Institute of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT00907270
Brief Title
Supplementation With Vitamin D Improves Leptin Resistance
Official Title
Effect of Vitamin D Supplementation on Leptin Resistance, Hunger, Body Weight and Resting Energy Expenditure in Obese Women.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Mexican National Institute of Public Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol: 400 IU/day
Arm Type
Active Comparator
Arm Description
Control: (n=50) Each subject will be evaluated after supplementation during six months with Vitamin D (Cholecalciferol: 400 IU/day)
Arm Title
Cholecalciferol 4000 IU/day
Arm Type
Experimental
Arm Description
Experimental: (n=50) Each subject will be evaluated after supplementation during six months with Vitamin D
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Cholecalciferol supplementation (400 IU and 4000 IU)
Intervention Description
Cholecalciferol: 4,000 IU/day and 400 IU/day
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Flores-Aldana, MsC
Phone
(52)777-329-30-00
Ext
7451
Email
mflores@insp.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Nayeli Macías-Morales, MsC
Phone
(52)777-329-30-00
Ext
7451
Email
nmacias@insp.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Flores-Aldana, MsC
Organizational Affiliation
National Institute of public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Social Insurance
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62450
Country
Mexico

12. IPD Sharing Statement

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