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
Key facts
- Where
- Prague, CsehországSee the site
- Phase
- 3. fázis
Where in Csehország
- Fakultni nemocnice v MotolePrague, CsehországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fakultni Nemocnice V Motole
- Trial code
- EU 2024-517886-18-00
- Record updated
- 2024. október 2.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Lung transplantation (done or planned); 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); Contraindication done by SmPC of Vigantol; Bisphosphonate treatment in the last 18 months; Hypercalcaemia; Renal osteodystrophy with hyperphosphatemia; Pregnancy.