The randomized, double blind study phase III.b of the Comprehensive assessment of the musculoskeletal health in children with cystic fibrosis â on the search for means of improvement
Study design (if review, criteria of inclusion for studies)
Controlled: No.1 Randomised: Yes.2 Open: No.3 Single blind: No.4 Double blind: Yes.5 Parallel group: No.6 Cross over: No
Participants
Principal inclusion criteria: Diagnosis of CF; Age 8-16 years
Interventions
Main objective of the trial: 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.
Outcome measures
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.
Keywords: Bone Density Conservation Agents; Bone Diseases; Gastrointestinal Diseases; Pancreas insufficiency; Pancreatic Diseases; pharmacological_intervention; Supplementation; vitamins; Vitamin D; Vitamin D Deficiency; Vitamin deficiencies; Malabsorption; Powders;