NCT07497776

Atorvastatin Therapy in the Treatment of Dyslipidemia in Children With Steroid Sensitive Nephrotic Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: National Institute of Kidney Disease and Urology (NIKDU) · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effectiveness and safety of Atorvastatin therapy in children with dyslipidemia in steroid sensitive nephrotic syndrome.

Detailed description

Abstract Background: Dyslipidemia is a common complication in children with steroid-sensitive nephrotic syndrome (SSNS), which often persists during remission. It increases the risk of early atherosclerosis, cardiovascular disease, and progressive kidney damage. Lifestyle and dietary measures are often insufficient, and evidence on the use of statins such as atorvastatin in this population remains fairly unexplored. Objective: To evaluate the effectiveness and safety of Atorvastatin therapy in children with dyslipidemia in steroid sensitive nephrotic syndrome. Methods: This quasi-experimental study was conducted at the department of Pediatric Nephrology \& Nephrology department, National Institute of Kidney Diseases \& Urology, Dhaka. A total of 100 children aged between 8-18 years with SSNS having dyslipidemia in two consecutive measurements, 1 month apart while in remission and who were free of infection were enrolled in the study. Participants were quasi-randomized into two groups: group A (dietary advice only n=50) (control group) and group B (dietary advice plus atorvastatin, n=50) (intervention group). Lipid profiles (total cholesterol, Triglyceride, Low density Lipoprotein and High Density Lipoprotein) were measured at baseline, 1, 3 and 6 months. During study in total 9 patients were lost to follow up and 2 patients were withdrawn from study. Outcome variable was percentage of patients achieving target levels of lipid profile within 3 months and 6 months in both groups. Safety was also assessed by monitoring of adverse events.

Conditions

• Dyslipidaemia

Interventions

Type	Name	Description
DRUG	Atorvastatin	Atorvastatin 10 mg nightly dose

Timeline

• Start date: 2024-01-27
• Primary completion: 2025-08-30
• Completion: 2025-10-31
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Bangladesh