RecruitingNot ApplicableNCT07206537

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


Sponsor

Ain Shams University

Enrollment

60 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 YearMax Age: 16 Years

Inclusion Criteria2

  • 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 Criteria6

  • 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.

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Interventions

DRUGVitamin K 2

Oral vitamin K2 supplementation


Locations(1)

Ain Shams University

Cairo, Egypt

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NCT07206537