Vitamin D and Chronic Renal Insufficiency
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test
研究概览
简要总结
Purpose of this study is to investigate the effect of treatment with vitamin D3 (cholecalciferol) compared with placebo in a trial including chronic kidney disease patients with vitamin D deficiency.
详细描述
Most patients with chronic renal insufficiency have vitamin D deficiency. It is still not common practice among nephrologists to monitor and correct vitamin D deficiency of chronic kidney disease (CKD) patients, because it is widely believed that any vitamin D deficiency associated with calcium-phosphate disturbances is better treated with activated vitamin D.
However, correction of vitamin D deficiency with native vitamin D seems to have numerous favorable effects not only related to the renal and intestinal handling of calcium and phosphate. It may have beneficial effects on bone and vascular health, the immune system and physical performance that are not obtained with active vitamin D treatment.
We are therefore planning a randomized, placebo-controlled, intervention study of 8 weeks' duration in which vitamin D3 supplementation (40 000 IE per week in one capsule) is compared with placebo in a trial including 120 CKD patients with vitamin D deficiency. Multiple biological variables are monitored in order to assess any effect on the biological systems of interest.
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
- 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
- •Chronic kidney disease (CKD 3-5 amd renal transplanted patients)
- •Age > 18 years
- •Vitamin D insufficiency or deficiency (25-OHD < 50 nmol/l, 3 months before project start)
排除标准
- •Treatment with vitamin D2/D3 (dose more than 10000 IU within the last 3 months)
- •Hypercalcaemia (ca++ > 1,35 mmol/l more than 4 weeks despite missing intake of calcium containing preparations and activated vitamin D)
- •Uncontrolled hyperphosphataemia (s-phosphate > 2,2 mmol/l)
- •Sarcoidosis
- •Malignant disease
- •Psychotic disorders
- •Pregnancy and lactation women
- •Allergy to soya and peanut
研究组 & 干预措施
Cholecalciferol
干预措施: Cholecalciferol (Drug)
Placebo
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test
时间窗: 8 weeks
次要结局
- Health questionnaire(8 weeks)