Despite supplementation with standard multivitamins and pancreatic enzymes, deficiencies of vitamins D and K and antioxidants are common in cystic fibrosis (CF).
Methods
In this non-randomized, open-label study, AquADEKs® softgels were given daily over 12 weeks to 14 CF subjects (mean age 15 years, range 10–23) without a preceding wash-out period. Both pancreatic sufficient and insufficient subjects were enrolled. Plasma vitamin and antioxidant levels, urine 8-isoprostane levels, anthropometric measures, and pulmonary function were determined at baseline, 6 and 12 weeks.
Results
Daily supplementation significantly increased plasma beta(β)-carotene, coenzyme Q10, and γ-tocopherol concentrations, decreased proteins induced in vitamin K absence (PIVKA-II) levels, but did not normalize vitamin D and K status in all subjects. Vitamin A levels did not exceed the normal range for any subject during the entire study period. Modest improvements in weight percentile and pulmonary function were observed. Change in plasma β-carotene concentrations weakly correlated with changes in weight and body mass index percentiles.
Conclusions
In this study, AquADEKs® increased systemic antioxidant levels, while maintaining vitamin A levels in the normal range, and improved but did not completely normalize vitamin D and K status. Increased β-carotene levels were associated with improved growth parameters. These results warrant further clinical evaluation in CF.
This research was supported by the Cystic Fibrosis Foundation, Yasoo Health Inc., the National Institutes of Health (K23 RR018611-05, U01 HL081335-05), and Colorado CTSA grant 1 UL1 RR025780 from NCRR/NIH.
