Improved residual fat malabsorption and growth in children with cystic fibrosis treated with a novel oral structured lipid supplement: A randomized controlled trial.
Study design (if review, criteria of inclusion for studies)
Double-blind randomized active placebo-controlled trial
Participants
Children with cystic fibrosis (CF) and pancreatic insufficiency (PI). Subjects (n = 66, 10.5+/-3.0 yrs, 39% female) with baseline CFA who completed a three-month treatment with Encala or a calorie and macronutrient-matched placebo were included in this subgroup analysis. Subjects were categorized by median baseline CFA: low CFA (<88%) and high CFA (>/=88%).
Interventions
A readily absorbable structured lipid (Encala, Envara Health, Wayne, PA)
Outcome measures
At baseline and 3-month evaluations, CFA (72-hour stool, weighed food record) and height (HAZ), weight (WAZ) and BMI (BMIZ) Z-scores were calculated. Fasting plasma fatty acid (FA) concentrations were also measured.
Main results
Subjects in the low CFA subgroup had significantly improved CFA (+7.5+/-7.2%, mean 86.3+/-6.7, p = 0.002), and reduced stool fat loss (-5.7+/-7.2 g/24 hours) following three months of EncalaTM treatment. These subjects also had increased plasma linoleic acid (+20%), alpha-linolenic acid (+56%), and total FA (+20%) (p
Authors' conclusions
Subjects with CF, PI and more severe fat malabsorption experienced greater improvements in CFA, FA and growth after three months of Encala treatment. Encala was safe, well-tolerated and efficacious in patients with CF and PI with residual fat malabsorption and improved dietary energy absorption, weight gain and FA status in this at-risk group.