Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in total serum 25-hydroxyvitamin D [25(OH)D] levels (ng/mL)
研究概览
简要总结
This study is to research two questions. First, is vitamin D3 more effective than vitamin D2 in raising 25-hydroxyvitamin D [25(OH)D] levels in chronic kidney disease (CKD) patients? And secondly, what are the differential effects of vitamin D2 and vitamin D3 on other mineral metabolism parameters?
详细描述
Vitamin D helps form and strengthens bones by allowing the body to absorb calcium. Vitamin D helps the immune system fight infection as well as helps keep muscles strong. Without enough vitamin D, bones can become weak, thin and brittle.
Vitamin D is useful in people with various types of health issues. Patients with CKD exhibit an unusually high rate of vitamin D deficiency, which may contribute to some of the poor clinical outcomes in this group.
This study will randomize patients with CKD and low vitamin D levels to two groups; one group will be treated with vitamin D2 (ergocalciferol) and the other group will be treated with vitamin D3 (cholecalciferol). The purpose of this study is to compare the effects of the two different forms of vitamin D specifically in patients chronic kidney disease.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and above
- •Chronic kidney disease with an estimated glomerular filtration rate (GFR) between 15-60 ml/min (CKD stage III-IV)
- •Vitamin D insufficiency (25-hydroxyvitamin D level < 30 ng/mL) that has not been treated with vitamin D replacement since the acquisition of this level
排除标准
- •Current treatment with cholestyramine
- •Presence of GI disorders such as short bowel, history of gastrectomy, colectomy, gastric bypass, inflammatory bowel disease, celiac disease, disorders of fat absorption, chronic diarrhea.
- •Liver cirrhosis
- •Known current substance abuse
- •Current treatment with immunosuppressant medications
- •Presence of chronic infection
- •History of chronic inflammatory disease (i.e. - lupus, active rheumatoid arthritis, Crohns disease)
- •Currently receiving high-dose vitamin D replacement (avg dose of ≥ 3,000 U per day) or "active" vitamin D analogue (e.g., calcitriol, which is 1,25-dihydroxyvitamin vitamin D).
研究组 & 干预措施
Vitamin D2 (ergocalciferol)
50,000 units once a week for 12 weeks
干预措施: Vitamin D2 (ergocalciferol) (Dietary Supplement)
Vitamin D3 (cholecalciferol)
50,000 units once a week for 12 weeks
干预措施: Vitamin D3 (cholecalciferol) (Dietary Supplement)
结局指标
主要结局
Change in total serum 25-hydroxyvitamin D [25(OH)D] levels (ng/mL)
时间窗: Baseline to immediately post-therapy (week 12)
次要结局
- Change in total serum 25(OH)D (ng/mL)(week 12 to week 18)
- Change in serum 25-hydroxyvitamin D2 and D3 subfractions (ng/mL)(Baseline to immediately post-therapy (week 12), and week 12 to week 18)
- Change in serum intact parathyroid hormone (PTH) (pg/mL)(Baseline to week 12)
研究者
Jason Stubbs, MD
Assistant Professor
University of Kansas Medical Center