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Clinical Trials/CTRI/2008/091/000057
CTRI/2008/091/000057
Completed
Phase 3

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 sites114 target enrollmentTBD
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ConditionsHealth Condition 1: null- Frequently relapsing nephrotic syndrome

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: null- Frequently relapsing nephrotic syndrome
Sponsor
I
Enrollment
114
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
I

Eligibility Criteria

Inclusion Criteria

  • •?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.

Exclusion Criteria

  • •?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.

Outcomes

Primary Outcomes

Not specified

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