Effect of Zinc Supplementation on Sustained Remission in Children with Nephrotic Syndrome: A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Sustained remission (i.e., no relapse after initial remission)
研究概览
简要总结
Nephrotic Syndrome is a common pediatric glomerular disease. While most children respond to corticosteroids, many experience relapses, often triggered by infections. Zinc, an essential micronutrient for immune function, has been linked to reduced infection risk and improved T-cell responses. Trials suggest zinc supplementation may lower relapse frequency in children with Nephrotic Syndrome, but variations in study design and outcomes limit firm conclusions. Most studies also evaluate relapses only during supplementation. This study aims to address that gap by assessing whether standardized low-dose zinc supplementation over an intermediate duration with structured follow-up promotes sustained remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •First episode or relapse of nephrotic syndrome.
排除标准
- •Congenital Nephrotic Syndrome.
- •Steroid Dependent Nephrotic Syndrome or Frequently Relapsing Nephrotic Syndrome currently on low-dose steroids.
- •Steroid Resistant Nephrotic Syndrome.
- •Secondary Nephrotic Syndrome (e.g., diabetes mellitus, systemic lupus erythematosus, infections including hepatitis B/ hepatitis C/ HIV/ tuberculosis, malignancy, drug-induced).
- •Recent (within past 6 months) or concurrent use of other immunosuppressants (levamisole, cyclophosphamide, calcineurin inhibitors, rituximab).
- •Chronic systemic illness (e.g., chronic kidney disease).
- •Hypersensitivity to zinc supplementation.
结局指标
主要结局
Sustained remission (i.e., no relapse after initial remission)
时间窗: at the end of 6 months
次要结局
- Number of relapses over the study period.(noted on follow-ups during the study period of 6 months.)
- Time to first relapse after starting supplementation.(noted on follow-ups during the study period of 6 months.)
- Number of infection episodes during follow-up.(noted on follow-ups during the study period of 6 months.)
- Adverse effects of zinc like metallic taste, GI upset and others.(noted on follow-ups during the study period of 6 months.)
研究者
Varistha Shaw
All India Institute of Medical Sciences, Gorakhpur