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

NCT07206537 | Recruiting DMC

• 1 other identifier: FMASU MD189/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Pediatrics Nephrology

Keywords

Nephrotic Syndrome; Vitamin K2

Outcome Measures

Primary Outcomes (1)

• Prevention of Glucocorticoid-Induced Bone Loss

  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

  6 month

Study Arms (2)

Control

NO INTERVENTION

30 Nephrotic patients of matched age and sex of the cases have been on Glucocorticoids for 6 months or more not receiving vitamin k2 supplements

Case

ACTIVE COMPARATOR

30 Nephrotic patients of matched age and gender who have been on Glucocorticoids for 6 months or more, receiving vitamin k2 supplements for 24 weeks.

Drug: Vitamin K 2

Interventions

Vitamin K 2 DRUG

Oral vitamin K2 supplementation

Case

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Vitamin K 2

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Central Study Contacts

Noha Saied Ibrahim, Teaching Assistant

CONTACT

+201064099564; Nohasaied2000@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: April 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

EG (1)