CTRI/2026/02/102705尚未招募不适用
A Randomized Controlled Trial Comparing the Efficacy and Safety of Cholecalciferol versus Calcitriol in CKD-MBD Patients with Vitamin D deficiency.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- PGIMER
- 入组人数
- 66
- 试验地点
- 1
研究概览
简要总结
Despite widespread use of both cholecalciferol and calcitriol in managing vitamin D
deficiency among patients with Chronic Kidney Disease-Mineral and Bone Disorder
(CKDMBD), there is a lack of robust randomized controlled trials (RCTs) directly comparing
their efficacy and safety. Particularly, limited data are available regarding their effect on
vitamin D
metabolites and bone-specific biochemical markers in this patient population. This evidence
gap hinders clinical decision-making in choosing the optimal form of vitamin D therapy in
CKD-MBD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •CKD Stage 3 to 5 (not on dialysis) Serum 25(OH) D levels less than 20ng/mL Clinical or biochemical evidence of CKD-MBD.
排除标准
- •Serum calcium more than 10.5 mg/dL Serum iPTH less than 15 pg/mL History of parathyroidectomy Presence of bone diseases unrelated to CKD (e.g., multiple myeloma, bone metastases) Use of immunosuppressive drugs Diagnosed immune-mediated disorders (e.g., systemic lupus erythematosus, sarcoidosis) Critically ill or moribund patients Malabsorption syndrome Sepsis Malignancy Pregnancy or lactation Patients unable to take oral medications Patients not providing consent.
研究者
Aman Chaudhary
PGIMER Chandigarh
研究点 (1)
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