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Clinical Trials/CTRI/2025/10/095938
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

AIIMS Rishikesh1 site in 1 country92 target enrollmentStarted: November 15, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
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

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Prashant Kumar Verma

Department of pediatrics, AIIMS Rishikesh

Study Sites (1)

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