AzTrials
AzTrials

Bullosa EpidermolysisPhase 4NCT05141838

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

A Phase 4 study testing Vitamin D and Oral nutritional supplement in people with Bullosa Epidermolysis and Vitamin D Deficiency, run by National Medical Research Center for Children's Health, Russian Federation at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 0 to 17 years
What is being tested?
Vitamin D and Oral nutritional supplement
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteRussia
Study dates
21 Nov 2020to Jan 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • not planned

Trial locations and contacts

1 site in 1 country.

Russia1 site, 1 recruiting

  • National Medical Research Center for Children's Health

    Moscow, 119296

    Irina Yu. Pronina, +7(916)934-40-81, krapchatovaiv@yandex.ru

    Recruiting

Other trials in Russia

About this study

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.

Read the 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.

Being tested
Vitamin D, Oral nutritional supplement
Keywords
Children, Only
Medical subject headings
Epidermolysis Bullosa, Vitamin D Deficiency, Osteoporosis, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin DDrug

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

  • Oral nutritional supplementDietary supplement

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

Study groups in NCT05141838
Study groupRoleWhat they receive
Group 1 - Vitamin DExperimentalPatients receiving vitamin D supplements in therapy
Receives: Drug: Vitamin D
Group 2 - Oral nutritional supplementExperimentalPatients receiving oral nutritional supplement
Receives: Dietary Supplement: Oral nutritional supplement
Group 3 - Vitamin D+Oral nutritional supplementExperimentalPatients receiving vitamin D supplements and oral nutritional supplement in therapy
Receives: Drug: Vitamin D; Dietary Supplement: Oral nutritional supplement
Group 4 - No interventionNo interventionPatients with dystrophic form of congenital epidermolysis bullosa who have not taken vitamin D supplements and/or oral nutritional supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline

  2. 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

    Measured: 24 week

  3. Phosphorus-calcium metabolism assessment

    Study of levels of calcium, phosphorus, parathyroid hormone, creatinine, magnesium, albumin in the blood

    Measured: Baseline

  4. Phosphorus-calcium metabolism assessment

    Study of levels of calcium, phosphorus, parathyroid hormone, creatinine, magnesium, albumin in the blood

    Measured: 24 week

  5. Assessment of the state of bone tissue

    Study of levels of alkaline phosphatase, osteocalcin, b-CrossLaps, P1NP in the blood

    Measured: Baseline

  6. Assessment of the state of bone tissue

    Study of levels of alkaline phosphatase, osteocalcin, b-CrossLaps, P1NP in the blood

    Measured: 24 week

  7. Assessment of indicators of physical development

    Z-score calculation (weight-for-height z-score)

    Measured: Baseline

  8. Assessment of indicators of physical development

    Z-score calculation (weight-for-height z-score)

    Measured: 24 wee

Secondary outcomes (4)

  1. Assessment of bone mineral density

    dual-energy X-ray densitometry

    Measured: Baseline

  2. Assessment of bone mineral density

    dual-energy X-ray densitometry

    Measured: 24 week

  3. Bone age assessment

    X-ray of the bones of the hand with an assessment of bone age

    Measured: Baseline

  4. Bone age assessment

    X-ray of the bones of the hand with an assessment of bone age

    Measured: 24 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2021
  2. Study start21 Nov 2020
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completionJan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05141838
Sponsor's protocol ID
307308294
Status last verified
Dec 2021
First submitted
19 Nov 2021
Last updated
17 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitamin D and Oral nutritional supplement in people with Bullosa Epidermolysis and Vitamin D Deficiency, run by National Medical Research Center for Children's Health, Russian Federation at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vitamin D level (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05141838.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in