The efficacy of Encala was evaluated in an NIH-sponsored randomized, active placebo-controlled, double-blind study in patients with CF.1
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Study design
The efficacy of Encala was evaluated in a 12-month, active placebo-controlled double-blind clinical trial. Primary outcomes included the change in plasma fatty acids and the stool coefficient of fat absorption (CFA). -
Participants
110 children and adolescents 5 to 18 years of age with CF, exocrine pancreatic insufficiency (EPI), mild to moderate lung disease, and on pancreatic enzyme replacement therapy (PERT) were recruited from 10 CF centers in the United States. -
Methods
- Subjects 5 to 11 years of age consumed 2 servings per day of either Encala or the calorically similar active placebo
- Subjects 12 to 18 years of age consumed 3 servings per day of either Encala or the calorically similar active placebo
Results
Encala resulted in an 8% increase in mean CFA over three months among patients with a mean baseline CFA of 77%
Encala increased weight, height, and BMI for patients with CF who had the greater need
Encala improved absorption and blood levels of essential fatty acids, vitamins A and K, and choline
Encala significantly improves CFA (as shown by mean CFA results1)
Encala improved fatty acids and BMI in subjects with greater need1
- Subjects treated with Encala who had a baseline CFA <88% experienced a highly statistically and clinically significant increase in BMIZ score over three months (-0.51 to -0.31; change +0.20 Z score)
- Encala improved BMI as the result of an increase in both weight and height velocity, indicating catch-up growth