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High‐dose Cholecalciferol Supplementation in Adults with Cystic Fibrosis
Author(s) -
Janzen Kristin M.,
Sakon Colleen,
Lehman Angela,
Sommer Bekah,
Brown Cynthia
Publication year - 2019
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1002/phar.2307
Subject(s) - cholecalciferol , medicine , vitamin d and neurology , vitamin d deficiency , cystic fibrosis , gastroenterology , population , dosing , environmental health
Despite the availability of consensus guidelines for the treatment of vitamin D deficiency, prospective trials are lacking to examine alternative dosing strategies for adult patients with cystic fibrosis ( CF ) who do not meet therapeutic goals with standard regimens. Objectives The primary objective of this study was to determine the efficacy of high‐dose cholecalciferol supplementation in increasing serum vitamin D (25‐ OHD ) levels in adult patients with CF . Methods Patients were eligible for inclusion if they were 18 years or older, had baseline 25‐ OHD levels lower than 30 ng/ml, and were diagnosed with CF and pancreatic insufficiency. Patients were given a single dose of cholecalciferol 300,000 or 500,000 IU based on baseline 25‐ OHD levels. Response was defined by 25‐ OHD and ionized calcium levels at 3 months. At 6 months, responders received a second dose of the same strength, and nonresponders were given a weekly supplement of cholecalciferol 50,000 IU in addition to cholecalciferol 500,000 IU . A second 25‐ OHD level was obtained at 9 months. Results Of the 46 patients enrolled, 32 patients (70%) completed the study. Baseline levels of 25‐ OHD significantly increased over time in the per protocol population at 3 and 9 months. A total of 16 patients (50%) were considered nonresponders and required weekly supplementation. Conclusion A protocol using high‐dose cholecalciferol or high‐dose plus weekly cholecalciferol is safe and effective in treating adult patients with CF and pancreatic insufficiency.