Issn Print: 0277-2116
Publication Date: 1997/10/01
EFFECTIVENESS OF ADEKs® IN CYSTIC FIBROSIS AS A FAT SOLUBLE VITAMIN SUPPLEMENT, WITH SPECIAL ATTENTION TO VITAMIN K: 12
D C Wilson; M Rashid; P R Durie; A Tsang; D Kalnins; M Andrews; M Corey; J Shin; E Tullis; P B Pencharz
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Excerpt
Patients with CF risk developing fat soluble vitamin deficiency due to pancreatic insufficiency (PI) and/or CF-associated liver disease (CFLD). Further, indications for, and dosing requirements of, vitamin K (Vit K) supplementation in CF are controversial. Having reported sub-clinical Vit K deficiency in almost all children with PI (Pediatr Pulmonol 1996; Suppl. 13: 313), we then prospectively evaluated the effectiveness of ADEKs® (Scandipharm Inc., Birmingham, AL) as a Vit K, vitamin A (Vit A) and vitamin E (Vit E) supplement. In 75 children and adults (40 males) with PI and a mean (SD, range) age of 15 (11, 0.6-46) yr, daily vitamin supplements containing Vit A and Vit E, but not Vit K, were replaced by ADEKs, containing similar amounts of Vit A and Vit E. Before (pre) and at least 5 months after (post) starting ADEKs, plasma PIVKA-II (prothrombin induced in vitamin K absence) assay (ELISA; a sensitive indicator of vit K deficiency), prothrombin time (PT) and vit A and vit E assays (HPLC) were performed. Seven (9%) patients had CFLD with cirrhosis. Results below are mean (range); *p=0.004 by paired t test; **p=0.0001 by sign test. Table
The number (%) with subnormal Vit A was 5 (8%) both pre and post the change. Despite the drop in mean Vit E level, the number (%) with subnormal vit E rose insignificantly, from 7 (11%) to 8 (13%). By contrast, the number (%) with abnormal PIVKA-II fell significantly (p=0.001) from 67 (93%) to 42 (58%). Four patients (2 with CFLD) had prolonged PT (> 13.5 sec.) at both time periods. The median (range) PIVKA-II fell from 9.5 (5.5-55) to 2.2 (2.0-65) in the 7 patients with CFLD. We conclude that ADEKs is an effective supplement for vit A and vit E, and that it improves, but does not resolve the near universal problem of vit K deficiency in PI. We recommend further Vit K dosing studies be performed in CF patients with PI. (Funded by Scandipharm Inc., Birmingham, AL.
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