title: Growth and tolerance of infants fed formula with a new algal source of docosahexaenoic acid: Double-blind, randomized, controlled trial.
abstract: Docosahexaenoic acid (DHA) in infant formula at concentrations based on worldwide human milk has resulted in circulating red blood cell (RBC) lipids related to visual and cognitive development. In this study, infants received study formula (17mg DHA/100kcal) with a commercially-available (Control: n=140; DHASCO®) or alternative (DHASCO®-B: n=127) DHA single cell oil from 14 to 120 days of age. No significant group differences were detected for growth rates by gender through 120 days of age. Blood fatty acids at 120 days of age were assessed by capillary column gas chromatography in a participant subset (Control: n=34; DHASCO-B: n=27). The 90% confidence interval (91-104%) for the group mean (geometric) total RBC DHA (µg/mL) ratio fell within the pre-specified equivalence limit (80-125%), establishing study formula equivalence with respect to DHA. This study demonstrated infant formula with DHASCO-B was safe, well-tolerated, and associated with normal growth. Furthermore, DHASCO and DHASCO-B represented equivalent sources of DHA as measured by circulating RBC DHA.
authors.affiliation: Owensboro Pediatrics, 2200 E. Parrish Avenue, Owensboro, KY 42303, USA. Electronic address: Myeiser@owensboropediatrics.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Yeiser
authors.affiliation: Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN 47721, USA. Electronic address: cheryl.harris@mjn.com.
authors.forename: Cheryl L
authors.initials: CL
authors.lastname: Harris
authors.affiliation: Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN 47721, USA. Electronic address: ashlee.kirchoff@mjn.com.
authors.forename: Ashlee L
authors.initials: AL
authors.lastname: Kirchoff
authors.affiliation: Global Regulatory & Nutrition Science, Mead Johnson Nutrition, Evansville, IN 47721, USA. Electronic address: ashley.patterson@mjn.com.
authors.forename: Ashley C
authors.initials: AC
authors.lastname: Patterson
authors.affiliation: Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN 47721, USA. Electronic address: jennifer.wampler@mjn.com.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Wampler
authors.affiliation: Children's Research, LLC, 475 Osceola St, Suite 1100, Altamonte Springs, FL 32701, USA. Electronic address: ezissman@childrensresearch.net.
authors.forename: Edward N
authors.initials: EN
authors.lastname: Zissman
authors.affiliation: Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN 47721, USA. Electronic address: carol.berseth@mjn.com.
authors.forename: Carol Lynn
authors.initials: CL
authors.lastname: Berseth
mesh_terms: D053801:Capillary Electrochromatography; D002657:Child Development / Q000502:physiology*; D004281:Docosahexaenoic Acids / Q000097:blood*; D004311:Double-Blind Method; D005227:Fatty Acids / Q000032:analysis / Q000097:blood; D005260:Female; D005865:Gestational Age; D006801:Humans; D041943:Infant Formula / Q000737:chemistry*; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D008297:Male; D011446:Prospective Studies
chemical_list: D005227:Fatty Acids; D004281:Docosahexaenoic Acids