Vitamin D, C-reactive Protein and Insulin Resistance

This study has been completed.
Sponsor:
Collaborators:
Instituto Mexicano del Seguro Social
Ellison Medical / International Nutrition Foundation
Tufts University
Information provided by:
Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier:
NCT01019642
First received: November 23, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 23, 2009
November 23, 2009
March 2008
October 2008   (final data collection date for primary outcome measure)
  • Serum C-reactive protein concentrations, measured by a high-sensitivity assay -nephelometry-. [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Insulin resistance, measured by HOMA-IR index [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Serum 25-OH-vitamin D3 levels [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Vitamin D, C-reactive Protein and Insulin Resistance
Effect of Vitamin D Supplementation on C-reactive Protein and Insulin Resistance in Postmenopausal Women With Type 2 Diabetes Mellitus

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes
  • Low-intensity Chronic Inflammation
  • Insulin Resistance
  • Drug: cholecalciferol
    4,000 IU per day during 6 months. Capsule form.
  • Drug: placebo
    no active principles given.
  • Experimental: Vitamin D
    Cholecalciferol, 4,000 IU/d for 6 months
    Intervention: Drug: cholecalciferol
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: placebo
Flores M. A role of vitamin D in low-intensity chronic inflammation and insulin resistance in type 2 diabetes mellitus? Nutr Res Rev. 2005 Dec;18(2):175-82.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Female
45 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01019642
120-6371
Yes
Mario E. Flores, Instituto Nacional de Salud Publica
Instituto Nacional de Salud Publica, Mexico
  • Instituto Mexicano del Seguro Social
  • Ellison Medical / International Nutrition Foundation
  • Tufts University
Principal Investigator: Mario E Flores, MD, MSc Instituto Nacional de Salud Publica, Mexico
Instituto Nacional de Salud Publica, Mexico
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP