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

Completed

• Conditions: Nephrotic syndrome,

• Registration Number: CTRI/2021/11/037940
• Lead Sponsor: Institute of child health kolkata

Brief Summary

This study is a randomized parallel group active control trial comparing the safety and efficacy of prednisolone[2mg/kg/day]in daily single dose versus divided dose for 6 months in 60 patients with first episode of nephrotic syndrome that will be conducted in Institute Of Child Health,kolkata.The primary outcome measured will be comparison of effect of single dose versus divided dose prednisolone on HPA axis at the completion of 6 week daily treatment . The secondary outcomes will be documentation of time to remission and 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-12
• Study Completion: 2023-01-20
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	6 weeks

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Institute of child health kolkata,; 🇮🇳 Kolkata, WEST BENGAL, India

Institute of child health kolkata,

🇮🇳Kolkata, WEST BENGAL, India

Dr Tania Khan

Principal investigator

7278685725

taniacnmc92@gmail.com