2024-517886-18-00RecruitingPhase 3
The randomized, double blind study phase III.b of the Comprehensive assessment of the musculoskeletal health in children with cystic fibrosis – on the search for means of improvement
Source: EU CTIS (euclinicaltrials.eu) · Last updated 2 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this study is to assess whether 6000 IU of cholecalciferol per day given over two years to children with cystic fibrosis is superior to 1000 IU of cholecalciferol in normalizing their bone metabolism parameters and in improving their bone density and skeletal muscle force.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 6 Sept 2024
- Start date
- 2 Oct 2024
- Lead sponsor
- Fakultni Nemocnice V Motole
- Diseases
- Cystic fibrosis
- EU CT number
- 2024-517886-18-00
- EudraCT number
- 2022-002330-13
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 64
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children with cystic fibrosis. It compares two daily doses of vitamin D (cholecalciferol) over two years to see the effect on bones and muscle strength.
- Age
- 6 to 16 years (included)
- Sex
- Boys and girls can both join.
- Disease stage
- A diagnosis of cystic fibrosis is needed. No stage or severity is stated.
- Earlier treatment
- Children cannot join if they had bisphosphonate treatment in the last 18 months.
Main reasons for not taking part
- Lung transplantation, done or planned
- Bisphosphonate treatment in the last 18 months
- Another disease besides cystic fibrosis that is known to affect bone metabolism
- Hypercalcaemia
- Pregnancy
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Lung transplantation (done or planned)
Other illness
- Disease other than CF with known impact on bone metabolism (based on consultancy with main investigator)
- Hypersensitivity to the IMP or additive substance (as per SmPC)
Other
- Contraindication done by SmPC of Vigantol
- Bisphosphonate treatment in the last 18 months
- Hypercalcaemia
- Renal osteodystrophy with hyperphosphatemia
- Pregnancy
Who the study is looking for
- Diagnosis of cystic fibrosis
- Age from 6 to 16 (included) years
- Willingness of the parent or legal representative to sign the informed consent and allow the child participate in the study
- Woman of childbearing potential need to comply with adequate contraception methods per CTFG guideline
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fakultni nemocnice v Motole | Prague | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.