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Vitamin D, C-reactive Protein and Insulin Resistance

NCT01019642 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2009-11-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

cholecalciferol

4,000 IU per day during 6 months. Capsule form.

DRUG

placebo

no active principles given.

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV

  • Ellison Medical / International Nutrition Foundation

    collaborator UNKNOWN

  • Tufts University

    collaborator OTHER

  • Instituto Nacional de Salud Publica, Mexico

    lead OTHER

Principal Investigators

  • Mario E Flores, MD, MSc · Instituto Nacional de Salud Publica, Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01019642 on ClinicalTrials.gov