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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05141838
• Other study ID #: 307308294
• Status: Recruiting
• Phase: Phase 4
• Start date: November 21, 2020
• Est. completion date: January 2023

Study information

• Verified date: December 2021
• Source: National Medical Research Center for Children's Health, Russian Federation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• Verified diagnosis of epidermolysis bullosa;

• Signing by parents (legal representatives) of informed consent to participate in the study and fulfill the requirements of the study

Exclusion Criteria:

• not planned

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Epidermolysis Bullosa
• Osteopenia
• Osteoporosis
• Phosphorus and Calcium Disorders
• Vitamin D Deficiency

Intervention

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 ?ral nutritional supplement to the therapy depending on the degree of protein-energy malnutrition

Locations

Country	Name	City	State
Russian Federation	National Medical Research Center for Children's Health	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Medical Research Center for Children's Health, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D level	Study of the provision of vitamin D in children with dystrophic and simple forms of epidermolysis bullosa based on the level of 25 (OH) vitamin D (25 hydroxycholecalciferol) in the blood	Baseline
Primary	Vitamin D level	Study of the provision of vitamin D in children with dystrophic and simple forms of epidermolysis bullosa based on the level of 25 (OH) vitamin D (25 hydroxycholecalciferol) in the blood	24 week
Primary	Phosphorus-calcium metabolism assessment	Study of levels of calcium, phosphorus, parathyroid hormone, creatinine, magnesium, albumin in the blood	Baseline
Primary	Phosphorus-calcium metabolism assessment	Study of levels of calcium, phosphorus, parathyroid hormone, creatinine, magnesium, albumin in the blood	24 week
Primary	Assessment of the state of bone tissue	Study of levels of alkaline phosphatase, osteocalcin, b-CrossLaps, P1NP in the blood	Baseline
Primary	Assessment of the state of bone tissue	Study of levels of alkaline phosphatase, osteocalcin, b-CrossLaps, P1NP in the blood	24 week
Primary	Assessment of indicators of physical development	Z-score calculation (weight-for-height z-score)	Baseline
Primary	Assessment of indicators of physical development	Z-score calculation (weight-for-height z-score)	24 wee
Secondary	Assessment of bone mineral density	dual-energy X-ray densitometry	Baseline
Secondary	Assessment of bone mineral density	dual-energy X-ray densitometry	24 week
Secondary	Bone age assessment	X-ray of the bones of the hand with an assessment of bone age	Baseline
Secondary	Bone age assessment	X-ray of the bones of the hand with an assessment of bone age	24 week