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Supplementation With Vitamin D Improves Leptin Resistance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Mexican National Institute of Public Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Mexican National Institute of Public Health
ClinicalTrials.gov Identifier:
NCT00907270
First received: May 20, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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
Overweight
Obesity
Dietary Supplement: Cholecalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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).

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00907270

Contacts
Contact: Mario Flores-Aldana, MsC (52)777-329-30-00 ext 7451 mflores@insp.mx
Contact: Nayeli Macías-Morales, MsC (52)777-329-30-00 ext 7451 nmacias@insp.mx

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

No publications provided

Responsible Party: Mario Flores-Aldana, National Institute of Public Health
ClinicalTrials.gov Identifier: NCT00907270     History of Changes
Other Study ID Numbers: 69770
Study First Received: May 20, 2009
Last Updated: May 20, 2009
Health Authority: Mexico: National Council of Science and Technology
Mexico: National Institute of Public Health, Health Secretariat

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014