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Clinical Trials in Egypt / NCT07206537
Recruiting Not applicable

The Role of Vitamin K2 in Preventing Glucocorticoid-Induced Bone Loss in Children With Nephrotic Syndrome

NCT07206537 · tracked via the Priya Life Science Egypt tracker
Sponsor
Ain Shams University
Phase
Not applicable
Started
2025-04-01
Last updated
2025-10-03

Condition(s) studied

Pediatrics Nephrology

Investigational drug(s) / intervention(s)

Vitamin K 2 →

Vitamin K 2: Oral vitamin K2 supplementation

Study 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 been recently deemed appreciable as a topic of research as it plays a pivotal role in maintenance of the bone strength, and it has been proved to have a positive impact on the bone metabolism.

This study examines the impact of oral vitamin K2 supplementation on bone metabolism in pediatric patients with nephrotic syndrome on long-term steroid therapy, offering valuable therapeutic insights

Eligibility

Sex
ALL
Min age
1 Year
Max age
16 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: 1. Patients with impaired kidney functions. 2. Non-compliant patients on medications or vitamin supplements. 3. Diseases that affect fat-soluable vitamins absorption such as gallbladder or biliary disease, cystic fibrosis, celiac disease, etc. 4. History of vitamin K-related disorders as bleeding disorders, osteomalacia , etc. 5. History of bone fracture before the study. 6. Any nephrotic syndrome with identified genetic causes.

Primary outcome measure(s)

  • Prevention of Glucocorticoid-Induced Bone Loss — 6 month
    To assess the impact of vitamin K2 supplementation on glucocorticoid-induced bone loss in pediatric patients with nephrotic syndrome. To determine the effect of vitamin K2 on specific biochemical markers of bone turnover (e.g., bone-specific alkaline phosphatase , tartrate-resistant acid phosphate) in the study population

Trial sites (1)

FacilityCityRegionStatus
Ain Shams University Cairo Egypt Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07206537 on ClinicalTrials.gov ↗ ← All trials in Egypt