Growth and Tolerability of Healthy Term Infants Fed a New Formula Supplemented with DHA from Schizochytrium sp Microalgae

Mehta P, Shepard J, Rouse K, Sullivan T, McCarthy D, Yurko-Mauro K, Rooney M, Schallon D and Secic M

Objective: To evaluate growth and tolerability of infants fed a formula supplemented with docosahexaenoic acid (DHA) from a new strain of Schizochytrium sp (DHASCO®-B) microalgae. Methods: Healthy term infants (n=159) with weights ≥2500 gram were randomized on or before 14th day of life (DOL) to receive either DHASCO®-B or reference formula (DHASCO®) obtained from Crypthecodinium cohnii until DOL 120. Both formulas also contained arachidonic acid (ARA). Assessments included weight, length, weight/length ratio, head circumference, red blood cell (RBC) DHA and other fatty acids, metabolic panel, safety, and tolerance.
Results: The rate of mean daily weight gain (±SD) at DOL 120 was not significantly different between the formulas, 29.1 ± 5.92 grams/day versus 29.9 ± 7.40 grams/day for DHASCO® and DHASCO®-B, respectively and was equivalent (90% CI: -2.94 to 1.31; p=0.553). There was no significant difference between formulas in actual weight gain over time, i.e. DOL 30, 60, 90 and 120 (p=0.252), including by gender. Other anthropometric variables were also not different between the 2 groups. RBC DHA levels at DOL 120 were bioequivalent between the formulas (ratio of geometric means was 96.85%). There was no difference between formulas in any of the tolerance variables (watery stools, hard stools, gassiness, spitting up and fussiness), and no clinically meaningful difference in adverse events or laboratory values. Conclusions: There was no significant difference in daily weight gain of healthy term infants fed a formula supplemented with DHA from Crypthecodinium cohnii versus the new strain of Schizochytrium sp microalgae. Overall weight gains were equivalent between the two formula groups. Further, RBC DHA levels were bioequivalent, and there was no difference in infant tolerability or parent satisfaction. In summary, growth, tolerability and safety profiles for the formulas were similar and typical for this age group.