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

Diabetes Clinical Trial

Official title:

Does Administration of Vitamin D in African Americans With Hypovitaminosis D and Type 2 DM Improve Inflammatory Markers of Cardiovascular Disease?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01153243
• Other study ID #: #07-061
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 23, 2010
• Last updated: April 6, 2011
• Start date: April 2007
• Est. completion date: June 2011

Study information

• Verified date: March 2009
• Source: John H. Stroger Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 117
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes
• Vitamin D Deficiency

Intervention

Drug:
• Ergocalciferol
Active Comparator: Ergocalciferol The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)
• Placebo pill
The investigators will give control group 12 weeks of 1 placebo pill every week.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
John H. Stroger Hospital	Rush University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of inflammatory markers		baseline and 12 weeks	No
Secondary	Levels of Vitamin D, PTH and Calcium		Baseline and 12 weeks	No