BridgeMD
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
EU CTIS ID: 2024-517886-18-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Contraindication done by SmPC of Vigantol
- Lung transplantation (done or planned)
- Bisphosphonate treatment in the last 18 months
- 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)
- Hypercalcaemia
See the full eligibility criteria
- 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
- Contraindication done by SmPC of Vigantol
- Lung transplantation (done or planned)
- Bisphosphonate treatment in the last 18 months
- 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)
- Hypercalcaemia
- Renal osteodystrophy with hyperphosphatemia
- Pregnancy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.