Vitamin D and Inflammatory Markers of Cardiovascular Disease in African Americans With Type 2 Diabetes

Cook County Health

Status and phase: Unknown; Phase 4

Conditions: Diabetes; Vitamin D Deficiency

Treatments: Drug: Ergocalciferol; Drug: Placebo pill

Study type: Interventional

Funder types: Other

Identifiers

NCT01153243

#07-061

Details and patient eligibility

About

Recent clinical trials in non diabetics showed that vitamin D supplementation markedly reduced serum levels of C-reactive protein (CRP), interleukin-6, and tissue matrix metallo-proteinases. Our study objective is to evaluate if administration of vitamin D in African Americans with hypovitaminosis D and DM Type 2 decreases serum levels of inflammatory/thrombotic markers such as CRP: Highly Sensitive C Reactive Protein.

Full description

Other questions in our study: In diabetic African American patients,

1. Prevalence of vitamin D deficiency?
2. Correlation/relationship between vitamin D levels, Calcium level, parathyroid hormone (PTH) and Inflammatory markers

Setting: All visits will take place at the Fantus Diabetes Clinic.

Enrollment: 117 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• African Americans
• DM type 2

Exclusion criteria

• symptomatic vitamin D deficiency
• hypocalcemia
• hypercalcemia
• malabsorption
• liver disease
• patients with creatinine > 1.5. (CKD >/= 3)
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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117 participants in 2 patient groups, including a placebo group

Ergocalciferol

Active Comparator group

Description:

The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)

Treatment:

Drug: Ergocalciferol

Placebo pill

Placebo Comparator group

Description:

The investigators will give intervention group 12 weeks of placebo pill (in pill every week)

Treatment:

Drug: Placebo pill