Effect of Zinc Supplementation on Sustained Remission in Children with Nephrotic Syndrome: A Randomized Controlled Trial.
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- All India Institute of Medical Sciences, Gorakhpur.
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Sustained remission (i.e., no relapse after initial remission)
Overview
Brief Summary
Nephrotic Syndrome is a common pediatric glomerular disease. While most children respond to corticosteroids, many experience relapses, often triggered by infections. Zinc, an essential micronutrient for immune function, has been linked to reduced infection risk and improved T-cell responses. Trials suggest zinc supplementation may lower relapse frequency in children with Nephrotic Syndrome, but variations in study design and outcomes limit firm conclusions. Most studies also evaluate relapses only during supplementation. This study aims to address that gap by assessing whether standardized low-dose zinc supplementation over an intermediate duration with structured follow-up promotes sustained remission.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 1.00 Year(s) to 18.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •First episode or relapse of nephrotic syndrome.
Exclusion Criteria
- •Congenital Nephrotic Syndrome.
- •Steroid Dependent Nephrotic Syndrome or Frequently Relapsing Nephrotic Syndrome currently on low-dose steroids.
- •Steroid Resistant Nephrotic Syndrome.
- •Secondary Nephrotic Syndrome (e.g., diabetes mellitus, systemic lupus erythematosus, infections including hepatitis B/ hepatitis C/ HIV/ tuberculosis, malignancy, drug-induced).
- •Recent (within past 6 months) or concurrent use of other immunosuppressants (levamisole, cyclophosphamide, calcineurin inhibitors, rituximab).
- •Chronic systemic illness (e.g., chronic kidney disease).
- •Hypersensitivity to zinc supplementation.
Outcomes
Primary Outcomes
Sustained remission (i.e., no relapse after initial remission)
Time Frame: at the end of 6 months
Secondary Outcomes
- Number of relapses over the study period.(noted on follow-ups during the study period of 6 months.)
- Time to first relapse after starting supplementation.(noted on follow-ups during the study period of 6 months.)
- Number of infection episodes during follow-up.(noted on follow-ups during the study period of 6 months.)
- Adverse effects of zinc like metallic taste, GI upset and others.(noted on follow-ups during the study period of 6 months.)
Investigators
Varistha Shaw
All India Institute of Medical Sciences, Gorakhpur