cystic fibrosis E84
Conditions
Interventions
Group 1: Liposomal formulations of: vitamin A (2000 IU as retinyl palmitate/day), vitamin D (4000 IU as cholecalciferol/day), vitamin E (200 IU as alpha-tocopherol/day), vitamin K (0.2 mg of menaquino
Sponsors
Department of Pediatric Gastroenterology and Metabolic Diseases; Poznan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
16 Years to 55 Years
Inclusion criteria
Inclusion criteria: cystic fibrosis; exocrine pancreatic insufficiency
Exclusion criteria
Exclusion criteria: diagnosed liver cirrhosis; pregnancy; expected lung transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean (or median) change from the baseline in vitamin status in the serum: vitamin A (all-trans-retinol), vitamin D (25-hydroxyvitamin D), vitamin E (alpha-tocopherol), vitamin K (% of uncarboxylated osteocalcin) - after 90 days (+/- 4 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The mean (or median) change from the baseline in the prevalence of vitamin A, D, E, and K deficiency - after 90 days (+/- 4 days). 2. Planned (depends on feasibility): The mean (or median) change from the baseline of concentrations of vitamin K forms/homologues - after 90 days (+/- 4 days). 3. Planned (if the ANCOVA assumptions are met): ANCOVA for the above primary and secondary outcomes. | — |
Countries
Poland
Contacts
Public ContactJaroslaw Walkowiak
Department of Pediatric Gastroenterology and Metabolic DiseasesPoznan University of Medical Sciences
Outcome results
None listed