Hydrophilic formulation of lipophilic vitamins and carotenoids with excellent bioavailability in patients with cystic fibrosis

Abstract

Patients with cystic fibrosis (CF) show distinct vitamin deficits and elevated indicators of oxidative stress. We estimated fat soluble vitamins and carotenoids and protein carbonyls and TBARS in plasma and buccal mucosa (BM) of 22 patients with CF and 35 healthy controls. In patients with CF plasma and BM levels of fat soluble vitamins and carotenoids were significantly lower and markers of oxidative stress significantly higher compared to healthy volunteers. A subgroup Adult CF patients showed the lowest vitamin level and the highest indicators of oxidative stress. The major reason is the increasing fat malabsorption with the consequence a low absorption of fat soluble vitamins and carotenoids in these patients. To improve the absorption we tested a special “water soluble” formulation of vitamin A, E and β-carotene versus a conventional formulation in a clinical intervention trial (RCT) in 34 CF patients over a time period of 6 month. Plasma levels of vitamin A, E and β-carotene increased in the group treated with the micellised formulation, whereas in the group with the conventional formulation the levels remained either constant or tended to decrease. β-carotene increased significant in BM in the group with micellised formulation. Specifically the increase in plasma vitamin A documents that the patients suffered from a vitamin A deficiency despite plasma levels in a normal range. Despite nearly normal plasma levels of vitamin E and β-carotene the concentration of these compounds was very low in buccal mucosa cells prior supplementation compared to healthy volunteers. The new formulation offers a new and successful approach to supply fat soluble compounds in patients with fat malabsorption.