E84
Conditions
Interventions
Group 1: Liposomal formulations of: vitamin A (2667 IU as retinyl palmitate/day, 1333 IU as beta-carotene/day), vitamin D (4000 IU as cholecalciferol/day), vitamin E (150 IU as TPGS (d-a-tocopheryl po
beta-carotene 1428 IU/day), vitamin D (4000 IU as cholecalciferol/day), vitamin E (150 IU as alpha-tocopherol/day), vitamin K1 (2.14 mg of phylloquinone/day), for 90 days (for beta-carotene, vitamin E
Sponsors
Department of Pediatric Gastroenterology and Metabolic Diseases Poznan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
14 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 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 (i.e., blood draw within the last 10 days of the intervention). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change from the baseline in the prevalence of vitamin A, D, E, and K deficiency. 2. Planned (depends on feasibility): The change from the baseline of concentrations of vitamin K forms/homologues (incl. vitamin K1, vitamin K2 isoforms) and/or other biomarkers (dp-ucMGP, PIVKA-II). 3. The values of the above indicators (A, D, E, K/K1/K2, and also as deficiency prevalence) at the end of the study. 4. 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 Diseases Poznan University of Medical Sciences
Outcome results
None listed