E84
Conditions
Interventions
Group 1: Subjects will receive an MK-7 supplement at a dose of 300 mcg for 12 weeks, followed by a placebo capsule for the next 12 weeks. Both phases will be separated by a 4-week washout period.
Grou
Sponsors
Department of Pediatric Diabetes, Auxology and Obesity, Poznan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
13 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endothelial Nitric Oxide Synthase (eNOS), Vascular Cell Adhesion Molecule (VCAM), High-Sensitivity C-Reactive Protein (hsCRP), Asymmetric Dimethylarginine (ADMA). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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), Proteins Induced by Vitamin K Absence (PIVKA). | — |
Countries
Poland
Contacts
Public ContactAleksandra Lisowska
Department of Pediatric Diabetes, Auxology and Obesity, Poznan University of Medical Sciences
Outcome results
None listed