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

NCT06860620 | Completed

• 1 other identifier: PEDNEFMULTAN
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Steroid-Sensitive Nephrotic Syndrome

Outcome Measures

Primary Outcomes (1)

• Sustained remission

  Efficacy yes if sustained remission was seen after the treatment.

  6 months

Study Arms (2)

Zinc supplementation plus standard treatment group

EXPERIMENTAL

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

Standard treatment

NO INTERVENTION

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.

Interventions

Zinc supplementation plus standard treatment DRUG

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.

Zinc supplementation plus standard treatment group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Nishtar Hospital

Multan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 6, 2025
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)