Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
104 participants
INTERVENTIONAL
2008-03-31
2008-10-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vitamin D
Cholecalciferol, 4,000 IU/d for 6 months
cholecalciferol
4,000 IU per day during 6 months. Capsule form.
Placebo
placebo
placebo
no active principles given.
Interventions
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cholecalciferol
4,000 IU per day during 6 months. Capsule form.
placebo
no active principles given.
Eligibility Criteria
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Inclusion Criteria
* Postmenopausal
* Overweight or obesity (BMI \>=25)
* Treated with metformin
Exclusion Criteria
* Liver or kidney disease
* Other important chronic disease: i.e. cancer, autoimmune.
* Receiving insulin
45 Years
65 Years
FEMALE
No
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Ellison Medical / International Nutrition Foundation
UNKNOWN
Tufts University
OTHER
Instituto Nacional de Salud Publica, Mexico
OTHER
Responsible Party
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Instituto Nacional de Salud Publica
Principal Investigators
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Mario E Flores, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Salud Publica, Mexico
Locations
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Instituto Mexicano del Seguro Social
Cuernavaca, Morelos, Mexico
Countries
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References
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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. doi: 10.1079/NRR2005104.
Munoz-Aguirre P, Flores M, Macias N, Quezada AD, Denova-Gutierrez E, Salmeron J. The effect of vitamin D supplementation on serum lipids in postmenopausal women with diabetes: A randomized controlled trial. Clin Nutr. 2015 Oct;34(5):799-804. doi: 10.1016/j.clnu.2014.10.002. Epub 2014 Oct 13.
Other Identifiers
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120-6371
Identifier Type: -
Identifier Source: org_study_id