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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Steroid-Sensitive Nephrotic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Zinc supplementation plus standard treatment

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No