Supplementation With Vitamin D Improves Leptin Resistance

Mexican National Institute of Public Health

Status: Unknown

Conditions: Overweight; Obesity

Treatments: Dietary Supplement: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT00907270

69770

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Cholecalciferol: 400 IU/day

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Cholecalciferol

Cholecalciferol 4000 IU/day

Experimental group

Description:

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

Treatment:

Dietary Supplement: Cholecalciferol