临床试验/CTRI/2025/10/095938

CTRI/2025/10/095938尚未招募不适用

Role of zinc supplementation in reducing relapse rate in pediatric nephrotic syndrome: a randomized- controlled trial

AIIMS Rishikesh1 个研究点分布在 1 个国家目标入组 92 人开始时间: 2025年11月15日最近更新: 2025年10月13日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: AIIMS Rishikesh
入组人数: 92
试验地点: 1
主要终点: frequency of relapse rates

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Immunity has major role in the occurrence of relapse in nephrotic syndrome. Zinc plays a crucial role in rectifying immune dysfunction. Thus the study can help reducing the relapse rate and decreasing the disease burden. Recommended daily dietary Allowance For zinc will be administrated as per WHO guidelines.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Outcome Assessor Blinded

入排标准

年龄范围: 1.00 Month(s) 至 18.00 Year(s)（—）
性别: All

入选标准

•Newly diagnosed or any follow up case of steroid-sensitive nephrotic syndrome Informed consent from parents or legal guardians.

排除标准

•1.Steroid-resistant nephrotic syndrome 2.Congenital or secondary nephrotic syndrome 3.Severe or chronic infections (e.g., tuberculosis, HIV, hepatitis) 4.Chronic systemic illnesses or known zinc metabolism disorders 5.Ongoing zinc supplementation.

结局指标

主要结局

frequency of relapse rates

时间窗: six months from study enrolment

次要结局

To assess the effect of zinc supplementation on infection-related relapse rates. To assess the effect of zinc on the time to first relapse after remission.(To evaluate the number of infection episodes during the study period.)

研究者

发起方

AIIMS Rishikesh

申办方类型

Government medical college

责任方

Principal Investigator

主要研究者

Dr Prashant Kumar Verma

Department of pediatrics, AIIMS Rishikesh

研究点 (1)

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