ovel formulations for fat-soluble vitamin supplementation in cystic fibrosis

Not Applicable

• Conditions: cystic fibrosis; E84; Cystic fibrosis

• Registration Number: DRKS00014295
• 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: 2018-03-22
• Study Completion: 2018-11-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 77

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 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 Outcome Measures

Name	Time	Method
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).<br>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).<br>3. Planned (if the ANCOVA assumptions are met): ANCOVA for the above primary and secondary outcomes.