Vitamin supplementation in cystic fibrosis in the era of modulators: the impact of vitamin K2 on cardio-metabolic health – a randomised double-blind placebo-controlled trial

Not Applicable

Conditions: E84
Cystic fibrosis

Registration Number: DRKS00034742

Lead Sponsor: Department of Pediatric Diabetes, Auxology and Obesity, Poznan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 30

Inclusion Criteria

Diagnosed CF, receiving triple therapy (age> 12 years, genotype concordant with the ministerial program), pancreatic insufficiency, fat-soluble vitamin supplementation, and willingness to participate in the study.

Exclusion Criteria

Liver cirrhosis, organ transplantation, cachexia, other concomitant gastrointestinal CF non-related diseases interfering with digestion and absorption, diagnosed chronic severe diseases, vitamin MK-7 supplements in the last 3 months, lack of nutritional supervision by a dietician.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endothelial Nitric Oxide Synthase (eNOS), Vascular Cell Adhesion Molecule (VCAM), High-Sensitivity C-Reactive Protein (hsCRP), Asymmetric Dimethylarginine (ADMA).

Secondary Outcome Measures

Name	Time	Method
Fasting glucose and insulin, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), Total Cholesterol (TC), Low-Density Lipoprotein Cholesterol (LDL-C), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), vitamin K1, Menaquinone-4 (MK-4), Menaquinone-7 (MK-7), <br>Proteins Induced by Vitamin K Absence (PIVKA).