NCT05141838

Vitamin D Status and Bone Metabolism Status in Children With Congenital Epidermolysis Bullosa

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: National Medical Research Center for Children's Health, Russian Federation · Other Government
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This retrospective prospective study is aimed at studying the level of vitamin D supply and identifying markers of bone tissue remodeling in order to develop approaches to the prevention of osteopenia and osteoporosis in children with congenital epidermolysis bullosa.

Detailed description

This retrospective prospective interventional study will examine vitamin D availability and its relationship with clinical disease, patient gender and age, and season. The mechanisms of impairment of phosphorus-calcium metabolism and bone tissue metabolism will be analyzed on the basis of biochemical parameters and instrumental research methods in children with dystrophic epidermolysis bullosa in order to develop personalized approaches for correcting vitamin D status and bone metabolism disorders in children with epidermolysis bullosa, followed by an assessment of their clinical efficacy.

Conditions

• Bullosa Epidermolysis
• Vitamin D Deficiency
• Osteoporosis
• Osteopenia
• Phosphorus and Calcium Disorders

Interventions

Type	Name	Description
DRUG	Vitamin D	Adding vitamin D preparations to the therapy in the individual required dosage to correct the deficient state
DIETARY_SUPPLEMENT	Oral nutritional supplement	Adding оral nutritional supplement to the therapy depending on the degree of protein-energy malnutrition

Timeline

• Start date: 2020-11-21
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2021-12-02
• Last updated: 2021-12-17

Locations

1 site across 1 country: Russia