Growth and Tolerance of a Routine Infant Formula with an Alternative DHA Source Fed to Term Infants

Background Docasahexaenoic (DHA) and arachidonic acid (ARA) are long‐chain polyunsaturated fatty acids (LCPUFAs) important for fetal and infant development. When fed at concentrations based on worldwide human milk composition, DHA in infant formula is related to visual and cognitive development in term infants and has resulted in red blood cell (RBC) LCPUFA concentrations comparable to breastfed infants1,2. Commercially available algal‐derived DHA single cell oil (DHASCO) is generally recognized as safe (GRAS) for use in and at certain levels specified for infant formula. DHASCO also has a long history of safe use in infant formula. Recently, a new DHA‐rich single cell oil (DHASCO‐B) from an alternative marine algae source achieved GRAS status for a similar use. Objective The objective of this study was to establish that the investigational cow's milk‐based formula with an alternative DHA source (DHASCO‐B) compared to the marketed formula with the current DHA source (DHASCO; Control) provides adequate growth and dietary bioequivalence with respect to DHA. Methods In this multi‐center, double‐blind, randomized, controlled, parallel‐group, prospective study, infants received one of two study formulas with DHA at 17 mg/100 kcal: Control (n=140) or an investigational formula (DHASCO‐B, n=127). The primary outcome was growth rate from 14 to 120 days. Growth rates were analyzed by gender using ANOVA. A blood sample was collected at 120 days of age in a subset of participants (Control, n =34; DHASCO‐B, n=27). DHA and ARA concentrations in RBC (μg/mL) were assessed by capillary column gas chromatography. A 90% confidence interval (CI) was calculated for the ratio of the group mean (geometric) total RBC DHA concentration. Results There were no group differences in infant demographic or anthropometric characteristics at enrollment or study completion rate. No significant group differences were observed for weight, length, or head circumference growth rates by gender from 14 to 120 days of age. The calculated CI for total RBC DHA concentration for the investigational relative to the Control group (91 to 104%) fell within the pre‐specified equivalence limit (80 to 125%). No statistically significant differences (P<0.05) in total RBC DHA or ARA concentrations (μg/ml) (DHA: Control, 90.2 ±2.31; DHASCO‐B, 88.1 ±2.59 and ARA: Control, 243.6 ±4.68; DHASCO‐B, 240.8 ±5.25) or percent of total fatty acids (wt/wt) (DHA: Control, 5.52 ±0.12; DHASCO‐B, 5.52 ±0.13 and ARA: 14.90 ±0.24, DHASCO‐B: 15.15 ±0.27) were detected. Conclusions Results of this study demonstrated the investigational formula provided adequate growth and dietary bioequivalence when fed to healthy term infants from 14 to 120 days of age compared to the control formula with the traditional source of DHA. Support or Funding Information AC Patterson, KH Maditz, J Wampler, C Harris, A Kirchoff, and CL Berseth are full‐time employees of Mead Johnson Nutrition.