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

NCT ID: NCT05141838

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-21

Study Completion Date

2023-01-31

Brief Summary

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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

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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

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Bullosa Epidermolysis Vitamin D Deficiency Osteoporosis Osteopenia Phosphorus and Calcium Disorders

Keywords

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Children, Only

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 - Vitamin D

Patients receiving vitamin D supplements in therapy

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

Adding vitamin D preparations to the therapy in the individual required dosage to correct the deficient state

Group 2 - Oral nutritional supplement

Patients receiving oral nutritional supplement

Group Type EXPERIMENTAL

Oral nutritional supplement

Intervention Type DIETARY_SUPPLEMENT

Adding оral nutritional supplement to the therapy depending on the degree of protein-energy malnutrition

Group 3 - Vitamin D+Oral nutritional supplement

Patients receiving vitamin D supplements and oral nutritional supplement in therapy

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

Adding vitamin D preparations to the therapy in the individual required dosage to correct the deficient state

Oral nutritional supplement

Intervention Type DIETARY_SUPPLEMENT

Adding оral nutritional supplement to the therapy depending on the degree of protein-energy malnutrition

Group 4 - No intervention

Patients with dystrophic form of congenital epidermolysis bullosa who have not taken vitamin D supplements and/or oral nutritional supplement

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vitamin D

Adding vitamin D preparations to the therapy in the individual required dosage to correct the deficient state

Intervention Type DRUG

Oral nutritional supplement

Adding оral nutritional supplement to the therapy depending on the degree of protein-energy malnutrition

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Medical Research Center for Children's Health

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Facility Contacts

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Irina Yu. Pronina

Role: primary

Other Identifiers

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307308294

Identifier Type: -

Identifier Source: org_study_id