Randomized, double blind, placebo controlled trial to examine the effectiveness of zinc supplementation in reducing relapse rates in patients with frequently relapsing nephrotic syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- the rate of relapses in the two groups
研究概览
简要总结
this study is a randomized, double blind, parallel group placebo controlled trial to examine the effectiveness of zinc supplementation at 20 mg daily for one year in reducing relapse rates in 57 patients with frequently relapsing nephrotic syndrome. the study will be conducted at one centre in India. the primary outcome measure will be rate of relapses at one year. the secondary outcome measures will include rates of respiratory and diarrheal infections at one year, proportion of patients with sustained remission at one year, the time to first relapse in the two groups, growth velocity (height gain over 12 months), blood levels of zinc at enrollment and at one year, and gene expressions for TH1 and TH2 cytokines in PBMCs at enrollment and at one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •?Patients with steroid responsive nephrotic syndrome with frequent relapses or steroid dependence in the preceding six months ?Prednisolone requirement at <1 mg/kg on alternate day to maintain remission ?No zinc supplements in the preceding 3 months ?Parents willing to give informed written consent.
排除标准
- •?Grade IV protein energy malnutrition (Indian Academy of Pediatrics Classification)?Body mass index >30, height less than -2 SD of that expected (NCHS)?Patients with known secondary nephrotic syndrome (e.g., systemic lupus, infection with hepatitis B or C virus, amyloidosis)?Receiving immunosuppressive treatment other than oral prednisolone and levamisole (i.e., pulse dexamethasone or methylprednisolone, cyclophosphamide, cyclosporine, tacrolimus, azathioprine or mycophenolate mofetil) or having received such treatment during the previous six months?Known to have chronic infections e.g., tuberculosis, HIV, kala azar, hepatitis B or C or malignancy?More than one episode of a life threatening complication in the past 6 months, e.g., meningitis, sepsis, peritonitis, thrombosis or hypovolemic shock?Estimated glomerular filtration rate less than 60 ml/min/1.73 m2?Residing more than 100 km from the Institute or unwilling to come for regular follow-up.
结局指标
主要结局
the rate of relapses in the two groups
时间窗: one year
次要结局
- •Rates of respiratory and diarrheal infections•The proportion of patients with sustained remission •The time to first relapse in the two groups•Growth velocity (height gain over 12 months)•Blood levels of zinc during the course of nephrotic syndrome•Gene expressions for TH1 and TH2 cytokines in PBMCs(One year)