Diabetes, Vitamin D Deficiency
Conditions
Keywords
inflammatory markers
Brief 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.
Detailed 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.
Interventions
DRUGErgocalciferol
Active Comparator: Ergocalciferol The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)
DRUGPlacebo pill
The investigators will give control group 12 weeks of 1 placebo pill every week.
Sponsors
Rush University
Cook County Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of inflammatory markers | baseline and 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Levels of Vitamin D, PTH and Calcium | Baseline and 12 weeks |
Outcome results
None listed