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

Muhammad Aamir Latif

Status: Completed

Conditions: Steroid-Sensitive Nephrotic Syndrome

Treatments: Drug: Zinc supplementation plus standard treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06860620

PEDNEFMULTAN

Details and patient eligibility

About

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).

Full 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.

Enrollment: 192 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

Zinc supplementation plus standard treatment group

Experimental group

Description:

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.

Treatment:

Drug: Zinc supplementation plus standard treatment

Standard treatment

No Intervention group

Description:

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.