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Study of Zinc supplementation in children with Nephrotic Syndrome to see if it helps them stay well and avoid relapses.

Effect of Zinc Supplementation on Sustained Remission in Children with Nephrotic Syndrome: A Randomized Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094614
Enrollment
102
Registered
2025-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: N04- Nephrotic syndrome

Interventions

Intervention1: Zinc plus standard therapy: Zinc will be given 10 mg per oral OD for 3 months in addition to standard therapy. Control Intervention1: Standard therapy alone: Prednisolone as per protoco

Sponsors

All India Institute of Medical Sciences, Gorakhpur.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: First episode or relapse of nephrotic syndrome

Exclusion criteria

Exclusion criteria: 1. Congenital Nephrotic Syndrome. 2. Steroid Dependent Nephrotic Syndrome or Frequently Relapsing Nephrotic Syndrome currently on low-dose steroids. 3. Steroid Resistant Nephrotic Syndrome. 4. Secondary Nephrotic Syndrome (e.g., diabetes mellitus, systemic lupus erythematosus, infections including hepatitis B/ hepatitis C/ HIV/ tuberculosis, malignancy, drug-induced). 5. Recent (within past 6 months) or concurrent use of other immunosuppressants (levamisole, cyclophosphamide, calcineurin inhibitors, rituximab). 6. Chronic systemic illness (e.g., chronic kidney disease). 7. Hypersensitivity to zinc supplementation.

Design outcomes

Primary

MeasureTime frame
Sustained remission (i.e., no relapse after initial remission)Timepoint: at the end of 6 months

Secondary

MeasureTime frame
Number of relapses over the study period.Timepoint: noted on follow-ups during the study period of 6 months.;Time to first relapse after starting supplementation.Timepoint: noted on follow-ups during the study period of 6 months.;Number of infection episodes during follow-up.Timepoint: noted on follow-ups during the study period of 6 months.;Adverse effects of zinc like metallic taste, GI upset and others.Timepoint: noted on follow-ups during the study period of 6 months.

Countries

India

Contacts

Public ContactVaristha Shaw

All India Institute of Medical Sciences, Gorakhpur

drmahimamittal@gmail.com9415051567

Outcome results

None listed

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