CLINICAL TRIAL

Fat-Soluble Vitamins in Cystic Fibrosis and Pancreatic Insufficiency: Efficacy of a Nutrition Intervention Chiara Bertolaso, Veronique Groleau, Joan I. Schall, Asim Maqbool, Maria Mascarenhas, Norma E. Latham, Kelly A. Dougherty, and Virginia A. Stallings ABSTRACT Objectives: The aim of the study was to assess the impact of LYM-X-SORB (LXS), an organized lipid matrix that has been shown to be absorbable without pancreatic enzyme therapy on fat-soluble vitamin status in children with cystic fibrosis (CF) and pancreatic insufficiency (PI). Methods: Children with CF and PI were randomized to daily LXS or an isocaloric placebo comparison supplement for 12 months. Serum vitamins A (retinol), D (25-hydroxyvitamin D[25D]), E (a-tocopherol, a-tocopherol: cholesterol ratio), and K (percentage of undercarboxylated osteocalcin [%ucOC] and plasma proteins induced by vitamin K absence factor II [PIVKA II]) were assessed at baseline and 12 months. Dietary intake was determined using 3-day weighed food records and supplemental vitamin intake by a comprehensive questionnaire. Results: A total of 58 subjects (32 boys, age 10.3  2.9 years [mean  standard deviation]) with complete serum vitamin, dietary and supplemental vitamin data were analyzed. After adjusting for dietary and supplemental vitamin intake, serum retinol increased 3.0  1.4 mg/dL (coefficient  standard error) (adjusted R2 ¼ 0.02, P ¼ 0.03) and vitamin K status improved as demonstrated by a decreased percentage of undercarboxylated osteocalcin of 6.0%  1.6% by 12 months (adjusted R2 ¼ 0.15, P < 0.001). These changes occurred in both the LXS and placebo comparison groups. No changes in serum 25D or a-tocopherol were detected. Both nutrition interventions increased caloric intake a mean of 83  666 kcal/day by 12 months. Conclusions: Vitamins A and K status improved, whereas vitamins D and E status was unchanged during 12 months of LXS and isocaloric placebo comparison supplement in children with CF and PI. Key Words: children, cystic fibrosis, vitamin A, vitamin D, vitamin E, vitamin K

(JPGN 2014;58: 443–448) Received April 15, 2013; accepted November 26, 2013. From the Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. Address correspondence and reprint requests to Chiara Bertolaso, MD, The Children’s Hospital of Philadelphia, 3535 Market Street, Room 1556, Philadelphia, PA 19104 (e-mail: [email protected]). www.clinicaltrials.gov registration no.: NCT00406536. This study was supported by NIDDK (R44DK060302) and the Nutrition Center at The Children’s Hospital of Philadelphia. The study was also supported by the National Center for Research Resources (grant UL1RR024134) and is now at the National Center for Advancing Translational Sciences (grant UL1TR000003). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. V.A.S. received consulting honoraria and travel expenses from companies with interest in CF care. The other authors report no conflicts of interest. Copyright # 2014 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition DOI: 10.1097/MPG.0000000000000272

JPGN



Volume 58, Number 4, April 2014

A

pproximately 90% of patients with cystic fibrosis (CF) in the United States have pancreatic insufficiency (PI) and are at risk for fat malabsorption and fat-soluble vitamin deficiency (1). Each fat-soluble vitamin has multiple and essential metabolic functions for human health. Vitamin A is essential for normal vision, epithelial cell integrity, epithelial proliferation, and immunity (2). Vitamin D is required for bone health and has a role in immune function and incidence of cancer, type 1 diabetes mellitus, autoimmune disease, and heart disease (3–6). Vitamin E prevents cell membrane oxidation and maintains neurological functions, and studies reported a role in cognitive function in infants with CF (7,8). Vitamin K is essential for bone calcification, coagulation, energy metabolism, and modulation of inflammation (2,9). Even with effective pancreatic enzyme medications and CF-specific vitamin and mineral supplements, a portion of patients with CF and PI have suboptimal fat-soluble vitamin status (10–14). LYM-X-SORB (LXS; Avanti Polar Lipids, Alabaster, AL) is a choline-rich structured lipid matrix that was shown to be absorbed without pancreatic enzymes in subjects with CF and PI, and improves growth and vitamin A status using a first-generation LXS formulation (15). The primary aim of this report was to assess the effect of second-generation LXS on fat-soluble vitamin status. These data were collected as a part of the randomized placebo-controlled trial to evaluate choline status in children with CF and PI with LXS supplementation compared with an isocaloric placebo comparison supplement. The secondary aim of this report was to compare the fat-soluble vitamin status in this present sample to that of participants from a series of CF nutrition studies during the past decade.

METHODS Subjects with CF, PI, and mild-to-moderate lung disease ages 5.0 to 17.9 years were recruited from 10 CF centers at the beginning of March 2007 (last study visit May 2011) to participate in the CF Avanti study, a placebo-controlled double-blind study evaluating the impact of second-generation LXS on choline status. The exclusion criteria included forced expiratory volume in 1 second 15 mg/g stool), liver disease (serum g-glutamyltransferase >3 times reference range), or other chronic health conditions that may affect nutrient absorption or growth. The fecal elastase inclusion criteria (

Fat-soluble vitamins in cystic fibrosis and pancreatic insufficiency: efficacy of a nutrition intervention.

The aim of the study was to assess the impact of LYM-X-SORB (LXS), an organized lipid matrix that has been shown to be absorbable without pancreatic e...
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