Status:
RECRUITING
The Role of Vitamin K2 in Preventing Glucocorticoid-Induced Bone Loss in Children With Nephrotic Syndrome
Lead Sponsor:
Ain Shams University
Conditions:
Pediatrics Nephrology
Eligibility:
All Genders
1-16 years
Phase:
NA
Brief Summary
Long-term glucocorticoids therapy is associated with various complications, including decreased bone strength (Glucocorticoid-induced osteoporosis) and an increased risk of fracture. Vitamin K2 has b...
Detailed Description
Nephrotic syndrome is the predominant glomerular disorder in pediatric patients. It is defined as nephrotic-range proteinuria and either hypoalbuminemia (serum albumin \<30 g/l (3 g/di)) or edema when...
Eligibility Criteria
Inclusion
- Nephrotic patients under 16 years of age of both genders who were treated with GC for the first time. GC treatment was initiated at a dose of 2 mg/kg/day prednisolone with gradual dose reduction.
- All patients have been on glucocorticoid therapy for more than 6 months. All patients have sufficient vitamin D level 30 ng/ml (75 nmol/L) or above.
Exclusion
- Patients with impaired kidney functions.
- Non-compliant patients on medications or vitamin supplements.
- Diseases that affect fat-soluable vitamins absorption such as gallbladder or biliary disease, cystic fibrosis, celiac disease, etc.
- History of vitamin K-related disorders as bleeding disorders, osteomalacia , etc.
- History of bone fracture before the study.
- Any nephrotic syndrome with identified genetic causes.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07206537
Start Date
April 1 2025
End Date
April 30 2026
Last Update
October 3 2025
Active Locations (1)
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1
Ain Shams University
Cairo, Egypt