Objectives
To assess the impact of LYM-X-SORB™ (LXS), an organized lipid matrix that has previously been shown to be absorbable without pancreatic enzyme therapy on fat soluble vitamin status in children with CF and PI.
Methods
Children with CF and PI were randomized to daily LXS or an iso-caloric placebo comparison supplement for 12 months. Serum vitamins A (retinol), D (25-hydroxyvitamin D[25D]), E (α-tocopherol, α-tocopherol:cholesterol ratio) and K (%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
58 subjects (32 males, age 10.3±2.9 yrs [mean±SD]) 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 μg/dL (coefficient±SE) (Adj R2=0.02, p=0.03) and vitamin K status improved as demonstrated by a decreased %ucOC of −6.0±1.6% by 12 months (Adj R2=0.15, p<0.001). These changes occurred in both the LXS and placebo comparison groups. No changes in serum 25D or α-tocopherol were detected. Both nutrition interventions increased caloric intake a mean of 83±666 kcal/d by 12 months.
Conclusions
Vitamin A and K status improved, while vitamin D and E status was unchanged over 12 month of LXS and iso-caloric placebo comparison supplement in children with CF and PI.