A clinical trial to study whether zinc decreases the frequency of disease relapses in patients with frequently relapsing nephrotic syndrome

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000057

Enrollment

114

Registered

2008-05-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Frequently relapsing nephrotic syndrome

Interventions

Intervention1: zinc sulfate: 20 mg elemental zinc for 12 months Control Intervention1: placebo: for 12 months

Eligibility

Inclusion criteria

Inclusion criteria: ?Patients with steroid responsive nephrotic syndrome with frequent relapses or steroid dependence in the preceding six months ?Prednisolone requirement at ?No zinc supplements in the preceding 3 months ?Parents willing to give informed written consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
the rate of relapses in the two groupsTimepoint: one year	—

Secondary

Measure	Time frame
â?¢Rates of respiratory and diarrheal infections â?¢The proportion of patients with sustained remission â?¢The time to first relapse in the two groups â?¢Growth velocity (height gain over 12 months) â?¢Blood levels of zinc during the course of nephrotic syndrome â?¢Gene expressions for TH1 and TH2 cytokines in PBMCs Timepoint: One year	—

Countries

India

Contacts

Public ContactDr Arvind Bagga

arvindbagga@hotmail.com01126593472

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026