Oral Cholecalciferol (Vitamin D3) Therapy in Prevalent Hemodialysis Patients: A Randomized Placebo Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility objectives for this proof-of-concept study
研究概览
简要总结
Vitamin D is a prohormone obtained through diet, supplementation, or sun exposure. Once absorbed, this nutritional vitamin D undergoes a two-step reaction in the liver and in the kidney to become the active hormone, calcitriol. Besides the kidney, many other body tissues are capable of local vitamin D activation. This local tissue activity is important for maintenance of health and relies on adequate levels of nutritional vitamin D. Not only are dialysis patients deficient in calcitriol due to kidney failure, but they are also deficiency in nutritional vitamin D. Low levels of vitamin D have been associated with higher rates of death, heart and blood vessel disease, osteoporosis, falls, cancer, and autoimmune diseases. Despite this, there is a lack of randomized controlled trials (RCT) examining the effects of nutritional vitamin D in hemodialysis (HD) patients. The investigators hypothesize that long-term supplementation with nutritional vitamin D in HD patients improves survival and cardiovascular outcomes. Before embarking on a large scale RCT, the investigators propose a small pilot RCT with 20 hemodialysis patients to: i) To determine the effects of cholecalciferol (vitamin D3) in raising blood vitamin D levels; ii) To determine the feasibility and barriers to successful randomization and adherence to treatment protocols, which will inform subsequent studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participant is ≥ 18 years
- •Participant is on hemodialysis ≥ 3 months
排除标准
- •Serum calcium >2.75 mmol/L
- •On concurrent vitamin D treatment ≥ 800 IU/day. Includes ergocalciferol, cholecalciferol, calcedidiol, over-the-counter vitamin D. Does not include one-alpha calcidol (One Alfa®) or 1, 25 di-hydroxy-D3 (Rocaltrol® or Calcijex®)
- •Known hypersensitivity or allergy to Vitamin D
- •End stage liver disease
- •Severe untreated malabsorption or resection of large segment of small bowel
- •Lack of informed consent or inability to consent
- •Currently enrolled in a RCT
研究组 & 干预措施
Cholecalciferol
Cholecalciferol 50,000IU po once weekly for 12 continuous weeks.
干预措施: Cholecalciferol (Drug)
Placebo
Matching placebo po once weekly for 12 continuous weeks
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Feasibility objectives for this proof-of-concept study
时间窗: 1 year
1. To determine the proportion of consecutive HD patients that are eligible, the proportion of eligible patients that will consent to randomization, and of those randomized, the proportion that will comply with their group assignment. 2. To determine the treatment effect of oral cholecalciferol compared with placebo in raising serum 25(OH)D and 1,25(OH)2D levels in HD patients.
次要结局
- Six Minute Walk Test(1 year)
