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Vitamin D, C-reactive Protein and Insulin Resistance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01019642
First Posted: November 25, 2009
Last Update Posted: November 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Instituto Mexicano del Seguro Social
Ellison Medical / International Nutrition Foundation
Tufts University
Information provided by:
Instituto Nacional de Salud Publica, Mexico
  Purpose

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.


Condition Intervention Phase
Diabetes Low-intensity Chronic Inflammation Insulin Resistance Drug: cholecalciferol Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Supplementation on C-reactive Protein and Insulin Resistance in Postmenopausal Women With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Salud Publica, Mexico:

Primary Outcome Measures:
  • Serum C-reactive protein concentrations, measured by a high-sensitivity assay -nephelometry-. [ Time Frame: 3 and 6 months ]
  • Insulin resistance, measured by HOMA-IR index [ Time Frame: 3 and 6 months ]

Secondary Outcome Measures:
  • Serum 25-OH-vitamin D3 levels [ Time Frame: 3 and 6 months ]

Enrollment: 104
Study Start Date: March 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
Cholecalciferol, 4,000 IU/d for 6 months
Drug: cholecalciferol
4,000 IU per day during 6 months. Capsule form.
Placebo Comparator: Placebo
placebo
Drug: placebo
no active principles given.

Detailed Description:

Methods. Randomized, double blind, placebo-controlled clinical trial. We selected 104 postmenopausal women, ages 45 to 65, with uncomplicated T2DM and BMI ≥25. Women with history of kidney or liver disease, BMI>40, autoimmune disease or cancer were not included in the study.

Participants were randomly assigned to receive either a capsule containing 4,000 IU of vitamin D3 (cholecalciferol, n=52) or placebo (n=52), once a day during 6 months.

Outcome variables were serum CRP, measured with a high-sensitivity assay (nephelometry), and HOMA-IR. Serum vitamin D (25-OH-D) was measured by HPLC. Outcome variables were measured at baseline, and 3 and 6 months thereafter. All participants received diet and physical activity counseling, and visited the clinic for medical check-up once a month.

Baseline Results. Mean age was 56.8 ± 5.1 y. Baseline BMI was 30.7 ± 3.9. Median CRP concentration was 5.0 mg/L (Interquartile range: 1.0, 8.5). HOMA index at baseline was 7.13 ± 3.8. Serum 25-OH-D concentration at baseline was 54.5 ± 15.7 nmol/L (~22 ng/mL). Almost 94% of patients had baseline serum 25-OH-D levels <80 nmol/L, and 25% were below 40 nmol/L. No one had levels <20 nmol/L. There were no statistical differences on important variables by treatment group at the onset of study.

  Eligibility

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019642


Locations
Mexico
Instituto Mexicano del Seguro Social
Cuernavaca, Morelos, Mexico, 62450
Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Instituto Mexicano del Seguro Social
Ellison Medical / International Nutrition Foundation
Tufts University
Investigators
Principal Investigator: Mario E Flores, MD, MSc Instituto Nacional de Salud Publica, Mexico
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mario E. Flores, Instituto Nacional de Salud Publica
ClinicalTrials.gov Identifier: NCT01019642     History of Changes
Other Study ID Numbers: 120-6371
First Submitted: November 23, 2009
First Posted: November 25, 2009
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by Instituto Nacional de Salud Publica, Mexico:
vitamin D
diabetes
C-reactive protein
insulin resistance

Additional relevant MeSH terms:
Inflammation
Insulin Resistance
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Hypoglycemic Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Bone Density Conservation Agents