iposomal formulation of fat-soluble vitamins in cystic fibrosis

Not Applicable

• Conditions: E84; Cystic fibrosis

• Registration Number: DRKS00018814
• Lead Sponsor: Department of Pediatric Gastroenterology and Metabolic Diseases Poznan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-26
• Study Completion: 2019-12-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

cystic fibrosis; exocrine pancreatic insufficiency

Exclusion Criteria

diagnosed liver cirrhosis; pregnancy; expected lung transplantation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. The change from the baseline in the prevalence of vitamin A, D, E, and K deficiency.<br>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).<br>3. The values of the above indicators (A, D, E, K/K1/K2, and also as deficiency prevalence) at the end of the study.<br>4. Planned (if the ANCOVA assumptions are met): ANCOVA for the above primary and secondary outcomes.<br>