Overview

Vitamin D, C-reactive Protein and Insulin Resistance

Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
0
Participant gender:
Female
Summary
Randomized, double blind, placebo-controlled clinical trial of vitamin D supplementation (cholecalciferol, 4,000 IU/day for 6 months, in 104 postmenopausal women with type 2 diabetes mellitus. The objective was to evaluate the effect of vitamin D supplementation on C-reactive protein (CRP) and insulin resistance in women with type 2 diabetes mellitus (T2DM). The trial was conducted from March to October 2008 at the Hospital of the Mexican Social Security in Cuernavaca, Mexico.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Instituto Nacional de Salud Publica, Mexico
Collaborators:
Ellison Medical / International Nutrition Foundation
Instituto Mexicano del Seguro Social
Tufts University
Treatments:
Cholecalciferol
Ergocalciferols
Insulin
Vitamin D
Vitamins
Criteria
Inclusion Criteria:

- Type 2 diabetes mellitus w/ < 10 yrs of diagnosis

- Postmenopausal

- Overweight or obesity (BMI >=25)

- Treated with metformin

Exclusion Criteria:

- BMI >=40

- Liver or kidney disease

- Other important chronic disease: i.e. cancer, autoimmune.

- Receiving insulin