Does Administration of Vitamin D in African Americans With Hypovitaminosis D and Type 2 DM Improve Inflammatory Markers of Cardiovascular Disease?
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 117
- 主要终点
- Levels of inflammatory markers
研究概览
简要总结
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.
详细描述
Other questions in our study: In diabetic African American patients,
- Prevalence of vitamin D deficiency?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •African Americans
- •DM type 2
排除标准
- •symptomatic vitamin D deficiency
- •hypocalcemia
- •hypercalcemia
- •malabsorption
- •liver disease
- •patients with creatinine > 1.
- •(CKD >/= 3)
- •pregnancy
研究组 & 干预措施
Ergocalciferol
The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)
干预措施: Ergocalciferol (Drug)
Placebo pill
The investigators will give intervention group 12 weeks of placebo pill (in pill every week)
干预措施: Placebo pill (Drug)
结局指标
主要结局
Levels of inflammatory markers
时间窗: baseline and 12 weeks
次要结局
- Levels of Vitamin D, PTH and Calcium(Baseline and 12 weeks)