Vitamin D, C-reactive Protein and Insulin Resistance
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|ClinicalTrials.gov Identifier: NCT01019642|
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : November 25, 2009
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 or disease||Intervention/treatment||Phase|
|Diabetes Low-intensity Chronic Inflammation Insulin Resistance||Drug: cholecalciferol Drug: placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Vitamin D Supplementation on C-reactive Protein and Insulin Resistance in Postmenopausal Women With Type 2 Diabetes Mellitus|
|Study Start Date :||March 2008|
|Primary Completion Date :||October 2008|
|Study Completion Date :||October 2008|
Experimental: Vitamin D
Cholecalciferol, 4,000 IU/d for 6 months
4,000 IU per day during 6 months. Capsule form.
Placebo Comparator: Placebo
no active principles given.
- 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 ]
- Serum 25-OH-vitamin D3 levels [ Time Frame: 3 and 6 months ]
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
|Instituto Mexicano del Seguro Social|
|Cuernavaca, Morelos, Mexico, 62450|
|Principal Investigator:||Mario E Flores, MD, MSc||Instituto Nacional de Salud Publica, Mexico|