Effect of cholecalciferol supplementation on sarcopenia in sarcopenic end stage kidney disease patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To study the effect of cholecalciferol supplementation on sarcopenia in sarcopenic end stage renal disease patients
研究概览
简要总结
In this study cholecalciferol will be supplemented in sarcopenic end stage renal disease patients and effect on improvement on sarcopenia will be seen . Vitamin d will be supplemented in 60,000 international units once weekly in vitamin d deficient patients for 12 weeks and those who have sufficient levels of vitamin d will be given 60,000 international units every 15 days for 12 weeks. at the end of 12 weeks, they will be reassessed for improvement in sarcopenia. Those who not improved will be given further 12 weeks of vitamin d supplementation as described above, patients whose vitamin d levels increases >80 ng/dl will be excluded from the study. Effect of vitamin D supplementation on quality of life will be studied at baseline and at the end of supplementation (0 ands 6 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •End stage ren disease patients (ckd
- •dialysis and non dialysis patients).
排除标准
- •Age more than 60 years, bedridden patients, patients with malignancy, HIV, tuberculosis, chronic liver disease , pregnant women, already taking vitamin D supplementation for last 3 months before study enrollment.
结局指标
主要结局
To study the effect of cholecalciferol supplementation on sarcopenia in sarcopenic end stage renal disease patients
时间窗: 3 months and 6 months
次要结局
- To estimate the prevalence of sarcopenia in end stage kidney disease patients, to determine risk factors like age, gender, diabetes, hypertension, coronary artery disease , different hormonal deficiency or excess associated with sarcopenia in end stage kidney disease patients, to study improvement in quality of life after supplementation of cholecalciferol in sarcopenic end stage kidney disease patients(0 and 6 months)
研究者
Dr Disha Arora
ABVIMS PGIMER DR RML HOSPITAL NEW DELHI