【ChiCTR2100045116】Efficacy of Vitamin D Supplementation and Physical Activity in Improving Musculoskeletal Health in Individuals with Chronic Kidney Disease

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基本信息

登记号

ChiCTR2100045116

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2021-04-07

临床申请受理号

靶点

适应症

Chronic kidney disease

试验通俗题目

Efficacy of Vitamin D Supplementation and Physical Activity in Improving Musculoskeletal Health in Individuals with Chronic Kidney Disease

试验专业题目

Efficacy of Vitamin D Supplementation and Physical Activity in Improving Musculoskeletal Health in Individuals with Chronic Kidney Disease

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临床试验信息

试验目的

Aims of the study: To assess the improvement in musculoskeletal health in individuals with chronic kidney disease having 25 OH vitamin D deficiency by giving vitamin D3 (cholecalciferol) and increased physical therapy. Primary Objectives: To compare improvement in objective measure of musculoskeletal health as assessed by hand grip measure in individuals with chronic kidney disease randomized to either vitamin D3 alone or vitamin D3 along with targeted physical therapy. To compare the improvement in physical functioning in individuals with chronic kidney disease randomized to either vitamin D3 alone or vitamin D3 along with targeted physical therapy based on subjective questionnaires. To compare differences in musculoskeletal health as measured by change in muscular strength and physical functioning in individuals with chronic kidney disease randomized to either vitamin D3 alone or vitamin D3 along with targeted physical therapy. Secondary Objectives: To assess the improvement in serum 25OH vitamin D levels among patients with Chronic Kidney disease with vitamin D3 supplementations.

试验分类

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试验类型

随机平行对照

试验分期

Ⅰ期

随机化

Randomization will be performed via computer generated random numbers by a statistician. A block randomization strategy with individual blocks with varying multiples of 4 will be used to periodically balance the assignment in the 2 study arms. Randomization lists will be stratified by Hospitals (AKUH and kidney

盲法

Not stated

试验项目经费来源

None

试验范围

目标入组人数

28;18

实际入组人数

第一例入组时间

2012-01-01

试验终止时间

2016-12-31

是否属于一致性

入选标准

1. Patients aged 20 to 60 years; 2. CKD stage 2-4; 3. Patients with CKD and having creatinine of >=1.7 mg/dL for men and >=1.4 mg/dL for women will be screened; 4. Vitamin D deficient subjects (<=20 nmol/L) (32); 5. Able to provide written informed consent.；

排除标准

1. Patients with any transplant (due to use of immune-suppression); 2. Patients with CKD 5 or ESRD; 3. Patients receiving dialysis; 4. Patients who are under treatment for Vitamin D deficiency; 5. Patients who have some sort of known vitamin D deficiency related bone disease by history; 6. Subjects already maintained on steroids; 7. Patients Who Have Been On (25 Or 1, 25, OH Vitamin D Supplementation for Vitamin D Repletion- I/M in last One Year; 8. Patients with known chronic inflammatory disease, malignancy; 9. Subjects who cannot perform physical activity due to any disability or limiting condition; 10. Patients with known depression; 11. Patients with calcium and phosphorus product of > 70 mg/dl.；

研究者信息

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试验机构

None

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