NCT07206537 The Role of Vitamin K2 in Preventing Glucocorticoid-Induced Bone Loss in Children With Nephrotic Syndrome
| NCT ID | NCT07206537 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ain Shams University |
| Condition | Pediatrics Nephrology |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-04-01 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07206537 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 16 Years, studying Pediatrics Nephrology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07206537 currently recruiting?
Yes, NCT07206537 is actively recruiting participants. Contact the research team at Nohasaied2000@gmail.com for enrollment information.
Where is the NCT07206537 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07206537 clinical trial?
NCT07206537 is sponsored by Ain Shams University. The trial plans to enroll 60 participants.