in Malabsorbing Patients

Abstract In cystic fibrosis (CF), pancreatic insufficiency and a diminished bile acid pool cause malabsorption of im-portant nutrients and dietary components leading to defi-ciency, poor nutritional status, and oxidative stress. Of par-ticular significance is the malabsorption of fat-soluble nutri-ents and antioxidants, which are important for normal im-mune and neurologic function. Patients with CF often are deficient in these compounds despite supplementation with the current standard of care therapy. The objective was to compare the pharmacokinetic profile of this water-soluble vitamin E formulation (Aqua-E) with an oil-based softgel formulation in a malabsorbing patient population. Patients with CF who had documented malabsorption were recruited for participation in this pharmacokinetic study. Patients who met inclusion and exclusion criteria discontinued vitamin E supplementation, except for that in a multivitamin, for 7 to 21 days before the day of dosing. Patients were randomized to The investigation materials were provided by Yasoo Health Inc., Johnson City, TN. Experimental materials were donated by Eisai Food & Chemical Company, and Cargill Health and Food Technologies Eastman Chemical Company, which also conducted the TPG