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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002330-13-CZ

Enrollment

Registered

2022-06-22

Start date

2022-06-22

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

musculoskeletal health in children with cystic fibrosis MedDRA version: 20.0 Level: PT Classification code 10050713 Term: Vitamin D System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Vigantol Product Name: Vigantol Pharmaceutical Form: Oral drops Trade Name: Vigantol Product Name: Vigantol Pharmaceutical Form: Oral drops

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of CF Age 8-16 years Able and willing to sign the informed consent and participate in the study Are the trial subjects under 18? yes Number of subjects for this age range: 90 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Lung transplantation Bisphosphonate treatment Underlying disease that affects the bone metabolism other than CF Hypersensitivity to the IMP or additive substance (as per SMPC) Hypercalcaemia Renal osteodystrofy with hyperfosphatemia Other according to SMPC

Design outcomes

Primary

Measure	Time frame
Main Objective: Maximum recommended doses of vitamin D given over two years to children with CF will normalize bone metabolism parameters and improve bone density and skeletal muscle force.;Secondary Objective: Not Applicable;Primary end point(s): The planned examinations will make it possible to assess the effectiveness of vitamin D substitution, possibly adjust the dose, and further assess the degree of risk of fractures, or to start treatment for osteoporosis.;Timepoint(s) of evaluation of this end point: Taking a blood sample from which the current state of bone metabolism will be determined, X-ray examination of the spine (side image) to rule out asymptomatic vertebral body fractures, examination of bone density to assess bone quality and examination of muscle strength and performance. Vein blood sampling and urine samples will be performed at study initiation and at 3, 6, 12, 18, and 24-month intervals thereafter. An X-ray lateral image of the spine will be taken at the start of the study and then after 24 months Bone density and strength tests will be performed at the start of the study, after 12 and 24 months Examination of muscle strength and performance will take place at the start of the study, after 12 and 24 months	—

Measure

Time frame

Main Objective: Maximum recommended doses of vitamin D given over two years to children with CF will normalize bone metabolism parameters and improve bone density and skeletal muscle force.;Secondary Objective: Not Applicable;Primary end point(s): The planned examinations will make it possible to assess the effectiveness of vitamin D substitution, possibly adjust the dose, and further assess the degree of risk of fractures, or to start treatment for osteoporosis.;Timepoint(s) of evaluation of this end point: Taking a blood sample from which the current state of bone metabolism will be determined, X-ray examination of the spine (side image) to rule out asymptomatic vertebral body fractures, examination of bone density to assess bone quality and examination of muscle strength and performance. Vein blood sampling and urine samples will be performed at study initiation and at 3, 6, 12, 18, and 24-month intervals thereafter. An X-ray lateral image of the spine will be taken at the start of the study and then after 24 months Bone density and strength tests will be performed at the start of the study, after 12 and 24 months Examination of muscle strength and performance will take place at the start of the study, after 12 and 24 months

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Czech Republic

Contacts

Public ContactPediatrická klinika

Fakultní nemocnice v Motole

Ondrej.Soucek@fnmotol.cz+420224432258

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026