Efficacy of Zinc Supplementation in Maintaining Sustained Remission in Children With Steroid-sensitive Nephrotic Syndrome

February 28, 2025 updated by: Muhammad Aamir Latif
This study aims to fill the gaps by determining the efficacy of zinc supplementation in maintaining sustained remission in children with steroid sensitive nephrotic syndrome (SSNS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is a need to ascertain the efficacy of zinc supplementation in maintaining sustained remission in children with SSNS, thereby lowering the number of relapses and disease morbidity. The findings of this study could pave the way for reasonable evidence about the role of zinc supplementation is sustained remission in children with SSNS.

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Multan, Punjab, Pakistan, 66000
        • Nishtar Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Both genders
  • Aged 2-12 years
  • With steroid-sensitive nephrotic syndrome, with frequent relapses

Exclusion Criteria:

  • Children with steroid-resistant nephrotic syndrome
  • With a history of chronic systemic illness (cardiac, metabolic, malignancy, pulmonary, neurologic, or rheumatologic)
  • With a history of kidney disease like polycystic kidney disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zinc supplementation plus standard treatment group
Children were given 5 mg of elemental zinc sulfate as a single daily dose for children less than 4 years of age and 10 mg for children more than 4 years of age for a total duration of 6 months, along with standard therapy.
Drug: Zinc supplementation plus standard treatment
children were given 5 mg of elemental zinc sulfate as a single daily dose for children less than 4 years of age and 10 mg for children more than 4 years of age for a total duration of 6 months, along with standard therapy.
No Intervention: Standard treatment
Children received prednisolone at a dose of 60 mg/m2 per day for 4-8 weeks or less if they reached absence of proteinuria for 3 consecutive days, followed by 40 mg/m2 on alternate days for 2 weeks, followed by gradual tapering over 1-2 months to the minimum dose of 0.5 to 1 mg/kg/day for a total duration of 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained remission
Time Frame: 6 months
Efficacy yes if sustained remission was seen after the treatment.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhammad Aamir Latif

Investigators

  • Principal Investigator: Rabia Saleem, FCPS, Nishter Hospital Multan, Pakistan
  • Principal Investigator: Afsheen Asghar, FCPS, Nishter Hospital Multan, Pakistan
  • Principal Investigator: Sheeba Yousuf, FCPS, Nishter Hospital Multan, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEDNEFMULTAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared on a reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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