CTRI/2025/10/095938
Not yet recruiting
Not Applicable
Role of zinc supplementation in reducing relapse rate in pediatric nephrotic syndrome: a randomized- controlled trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- AIIMS Rishikesh
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- frequency of relapse rates
Overview
Brief Summary
Immunity has major role in the occurrence of relapse in nephrotic syndrome. Zinc plays a crucial role in rectifying immune dysfunction. Thus the study can help reducing the relapse rate and decreasing the disease burden. Recommended daily dietary Allowance For zinc will be administrated as per WHO guidelines.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 1.00 Month(s) to 18.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Newly diagnosed or any follow up case of steroid-sensitive nephrotic syndrome Informed consent from parents or legal guardians.
Exclusion Criteria
- •1.Steroid-resistant nephrotic syndrome 2.Congenital or secondary nephrotic syndrome 3.Severe or chronic infections (e.g., tuberculosis, HIV, hepatitis) 4.Chronic systemic illnesses or known zinc metabolism disorders 5.Ongoing zinc supplementation.
Outcomes
Primary Outcomes
frequency of relapse rates
Time Frame: six months from study enrolment
Secondary Outcomes
- To assess the effect of zinc supplementation on infection-related relapse rates. To assess the effect of zinc on the time to first relapse after remission.(To evaluate the number of infection episodes during the study period.)
Investigators
Dr Prashant Kumar Verma
Department of pediatrics, AIIMS Rishikesh
Study Sites (1)
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