Vitamin K2 to help prevent steroid-related bone loss in children with nephrotic syndrome

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

This tests whether daily oral vitamin K2 can help prevent bone loss in children with nephrotic syndrome who have been on long-term glucocorticoids.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 1 Year to 16 Years
• Sex: All
• Sponsor: Ain Shams University (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Cairo)
• Trial ID: NCT07206537 on ClinicalTrials.gov

What this trial studies

This interventional study gives oral vitamin K2 supplements to pediatric patients with nephrotic syndrome who have received glucocorticoids for more than six months and monitors changes in bone metabolism. Participants undergo baseline and follow-up measurements of bone health markers and clinical monitoring while continuing standard nephrotic syndrome care. The protocol excludes children with impaired kidney function, malabsorption disorders, prior fractures, genetic forms of nephrotic syndrome, or vitamin K–related disorders to isolate the effect of supplementation. The goal is to determine whether vitamin K2 improves biochemical and clinical indicators of bone strength in this vulnerable population.

Who should consider this trial

Good fit: Children under 16 with nephrotic syndrome who have been on glucocorticoid therapy for more than six months, have sufficient vitamin D levels, and do not have impaired kidney function or excluded comorbidities are ideal candidates.

Not a fit: Children with impaired kidney function, malabsorption of fat-soluble vitamins, prior fractures, genetic nephrotic syndromes, or known vitamin K disorders are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If effective, vitamin K2 supplementation could reduce steroid-related bone loss and lower future fracture risk in affected children.

How similar studies have performed: Some adult and biochemical studies suggest vitamin K2 can improve bone metabolism, but evidence specifically in children with steroid-induced bone loss is limited.

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.

Where this trial is running

Cairo

• Ain Shams University — Cairo, Egypt (Recruiting)

Study contacts

• Study coordinator: Noha Saied Ibrahim, Teaching Assistant

Conditions Pediatrics Nephrology; Nephrotic Syndrome; Vitamin K2