Vitamin D and Early Markers of Cardiovascular Disease in African Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Change from baseline in carotid intima-medial thickness
研究概览
简要总结
African-Americans have higher rates of cardiovascular disease morbidity and mortality, as well as vitamin D deficiency. Multiple observational studies have demonstrated an increased risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation between cardiovascular disease and vitamin D levels; however, there is a lack of interventional trials exploring this connection. The objective of this proposal is to address the hypothesis that treatment of vitamin D deficiency in African Americans with type 2 diabetes will improve subclinical markers of cardiovascular disease.
详细描述
This study will be a double blinded, randomized controlled trial of vitamin D3 supplementation, 4,000 international units per day versus 600 international units per day, for one year to determine the effects on markers of subclinical cardiovascular disease in African Americans with type 2 diabetes and vitamin D deficiency. Outcome assessment will focus on changes in carotid intima-medial thickness (CIMT - ultrasound of the thickness of blood vessels in the neck), as well as markers of systemic inflammation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •African Americans of both genders
- •Age 50-70 years
- •Type 2 diabetes (A1C < 9.0%), on stable therapy with oral medications, insulin, or a combination
- •25(OH)D level < 20 ng/ml
- •BP < 140/90 mmHg; LDL < 140 mg/dl
排除标准
- •Pregnancy
- •Cardiovascular disease
- •Stage 3 or worse chronic kidney disease
- •High urine or serum calcium or history of recurrent kidney stones
- •Unstable medical conditions or major systemic diseases such as malignancy
结局指标
主要结局
Change from baseline in carotid intima-medial thickness
时间窗: 0, 6, and 12 months
次要结局
- Urinary Calcium(0, 1, 3, 6, 9, and 12 months)
- Change from baseline in systemic inflammatory markers(0, 6, and 12 months)
- Serum calcium(0, 1, 3, 6, 9, and 12 months)