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Intermittent vs Alternate Daily Regimen of Prednisolone in Ambulatory Boys With Duchenne Muscular Dystrophy
Sponsor: Muhammad Aamir Latif
Summary
The alternate-day regimen is hypothesized to reduce hypothalamic-pituitary-adrenal (HPA) axis suppression and decrease steroid-related toxicity. Similarly, intermittent regimens aim to provide periodic steroid exposure sufficient for muscle preservation while allowing recovery periods to limit side effects. There is a critical need for localized, prospective data to determine which protocol offers the optimal balance of efficacy and safety for pediatric patients in Pakistan.
Official title: Efficacy and Safety of Intermittent vs. Alternate Daily Regimen of Prednisolone in Ambulatory Boys With Duchenne Muscular Dystrophy: A Randomized, Open-Label Trial
Key Details
Gender
MALE
Age Range
4 Years - 10 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-09-15
Completion Date
2027-03-15
Last Updated
2026-08-26
Healthy Volunteers
No
Conditions
Interventions
Alternate-day prednisolone
Patients will be given alternate-day administration of prednisolone at a dose of 0.75 mg/kg/day.
Intermittent prednisolone
Patients will be administered prednisolone at a dose of 0.75 mg/kg/day for 10 consecutive days, followed by a 10-day steroid-free period.
Locations (1)
Children's Hospital/University of Child Health Sciences
Lahore, Punjab Province, Pakistan