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A clinical trial to study the effect of single dose steroid versus divided dose steroid in patients with nephrotic syndrome

A prospective randomized control trial to compare the safety and efficacy of single dose prednisolone versus divided dose prednisolone in first episode of nephrotic syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/037940
Enrollment
60
Registered
2021-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N04- Nephrotic syndrome

Interventions

Intervention1: single dose prednisolone: children with first episode nephrotic syndrome in the intervention arm will be given prednisolone @2mg/kg/day as a single morning dose daily for 6 weeks Contr

Sponsors

Institute of child health kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children between 1 to 12 years , with first episode steroid naïve nephrotic syndrome and being commenced on prednisolone were included in this study.

Exclusion criteria

Exclusion criteria: 1.Children with previous history of nephrotic syndrome 2.Children already on steroids. 3.Children with allergy to egg or egg components . 4.Children below 1yr and above 12yrs.

Design outcomes

Primary

MeasureTime frame
Comparison of effect of single dose versus divided dose prednisolone on HPA axis at 6 weeks of treatment in children with first episode of nephrotic syndrome.Timepoint: 6 weeks

Secondary

MeasureTime frame
Documentation of the time to remission [Remission: urine albumin nil or trace (or proteinuria 4 mg/m2/h) for 3 consecutive early morning specimens] 2. Documentation of number of relapses and the time to first relapse (if any) in the two study groups till 6 months after completion of steroid therapy. Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Tania khan

Institute of child Health,kolkata

rajivsinha_in@yahoo.com9330819380

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 9, 2026