Overview

This trial is active, not recruiting.

Conditions vitamin d deficiency, diabetes
Treatments ergocalciferol, placebo pill
Phase phase 4
Sponsor John H. Stroger Hospital
Collaborator Rush University
Start date April 2007
End date June 2010
Trial size 117 participants
Trial identifier NCT01153243, #07-061

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)
ergocalciferol Drisdol
Active Comparator: Ergocalciferol The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)
(Placebo Comparator)
The investigators will give intervention group 12 weeks of placebo pill (in pill every week)
placebo pill
The investigators will give control group 12 weeks of 1 placebo pill every week.

Primary Outcomes

Measure
Levels of inflammatory markers
time frame: baseline and 12 weeks

Secondary Outcomes

Measure
Levels of Vitamin D, PTH and Calcium
time frame: Baseline and 12 weeks

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Does Administration of Vitamin D in African Americans With Hypovitaminosis D and Type 2 DM Improve Inflammatory Markers of Cardiovascular Disease?
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by John H. Stroger Hospital.