Supplementation With Vitamin D Improves Leptin Resistance

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00907270
• Other study ID #: 69770
• Status: Not yet recruiting
• Phase: N/A
• First received: May 20, 2009
• Last updated: May 20, 2009
• Start date: September 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2009
• Source: Mexican National Institute of Public Health
• Contact: Mario Flores-Aldana, MsC
• Phone: (52)777-329-30-00
• Email: mflores[@]insp.mx
• Is FDA regulated: No
• Health authority: Mexico: National Council of Science and TechnologyMexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Cholecalciferol
Cholecalciferol: 4,000 IU/day and 400 IU/day

Locations

Country	Name	City	State
Mexico	National Institute of Social Insurance	Cuernavaca	Morelos

Sponsors (1)

Lead Sponsor	Collaborator
Mexican National Institute of Public Health

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No