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Supplementation With Vitamin D Improves Leptin Resistance

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Mexican National Institute of Public Health.
Recruitment status was:  Not yet recruiting
Information provided by:
Mexican National Institute of Public Health Identifier:
First received: May 20, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted

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.

Condition Intervention
Dietary Supplement: Cholecalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Supplementation on Leptin Resistance, Hunger, Body Weight and Resting Energy Expenditure in Obese Women.

Resource links provided by NLM:

Further study details as provided by Mexican National Institute of Public Health:

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. [ Time Frame: basal, third and sixth month ]

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. [ Time Frame: Basal, third and sixth month ]

Estimated Enrollment: 50
Study Start Date: September 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Cholecalciferol supplementation (400 IU and 4000 IU)

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).


Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00907270

Contact: Mario Flores-Aldana, MsC (52)777-329-30-00 ext 7451
Contact: Nayeli Macías-Morales, MsC (52)777-329-30-00 ext 7451

National Institute of Social Insurance
Cuernavaca, Morelos, Mexico, 62450
Sponsors and Collaborators
Mexican National Institute of Public Health
Principal Investigator: Mario Flores-Aldana, MsC National Institute of public Health
  More Information

Responsible Party: Mario Flores-Aldana, National Institute of Public Health Identifier: NCT00907270     History of Changes
Other Study ID Numbers: 69770
Study First Received: May 20, 2009
Last Updated: May 20, 2009

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on April 28, 2017