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临床试验/CTRI/2008/091/000057
CTRI/2008/091/000057已完成3 期

Randomized, double blind, placebo controlled trial to examine the effectiveness of zinc supplementation in reducing relapse rates in patients with frequently relapsing nephrotic syndrome

I0 个研究点目标入组 114 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
114

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

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.

研究者

发起方
I

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