(09-04-10) The DIAMOND (DHA Intake And Measurement Of Neural Development)

Study: a double-masked, randomized controlled clinical trial of the maturation of infant visual acuity as a function of the dietary level of docosahexaenoic acid1,2,3

Eileen E Birch, Susan E Carlson, Dennis R Hoffman, Kathleen M Fitzgerald-Gustafson, Valeria LN Fu, James R Drover, Yolanda S Casta?eda, Laura Minns, Dianna KH Wheaton, David Mundy, John Marunycz and Deborah A Diersen-Schade

1 From the Retina Foundation of the Southwest Dallas TX (EEB DRH VLNF JRD YSCDKHW); the Department of Ophthalmology University of Texas Southwestern Medical Center Dallas TX (EEB); the Department of DieteticsNutrition University of Kansas Medical Center Kansas City KS (SECLM); the Department of Neurology Hoglund Brain Imaging Center University of Kansas Medical Center Kansas City KS (KMF-G); the Department of Ophthalmology University of Pittsburgh Medical Center Pittsburgh PA (VLNF); the Department of Psychology Memorial University St Johns Newfoundland (JRD); the Department of ObstetricsGynecology University of Missouri Medical Center Kansas City MO (DM);Mead Johnson Nutrition Evansville IN (JMDAD-S).
2 Supported by Mead Johnson Nutrition.
3 Address correspondence to EE Birch, Retina Foundation of the Southwest, 9900 North Central Expressway, Suite 400, Dallas, TX 75231. E-mail: [email protected] .
Background: The range of human milk docosahexaenoic acid (DHA) concentrations worldwide is much broader than the range explored in randomized clinical trials to date.
Objective: The primary objective was to determine the effect of 4 amounts of DHA supplementation on the visual acuity of formula-fed infants at 12 mo of age. Secondary objectives were to evaluate visual acuity maturation, red blood cell fatty acids, tolerance, anthropometric measures, and adverse events.
Design: This double-masked, randomized trial was conducted at 2 sites (Dallas and Kansas City). Three hundred forty-three healthy, term, formula-fed infants were enrolled at 1?9 d of age and were randomly assigned to be fed 1 of the following 4 infant formulas containing equivalent nutrient amounts, except for long-chain polyunsaturated fatty acids: control (0% DHA), 0.32% DHA, 0.64% DHA, or 0.96% DHA; DHA-supplemented formulas also provided 0.64% arachidonic acid. Visual acuity was measured by visual evoked potentials in 244 infants who completed the 12-mo primary outcome examination.
Results: Infants fed control formula had significantly poorer visual evoked potential visual acuity at 12 mo of age than did infants who received any of the DHA-supplemented formulas (P < 0.001). There were no significant differences in visual evoked potential visual acuity between the 3 amounts of DHA supplementation for either site at any age tested.
Conclusions: DHA supplementation of infant formula at 0.32% of total fatty acids improves visual acuity. Higher amounts of DHA supplementation were not associated with additional improvement of visual acuity. This trial was registered at clinicaltrials.gov as NCT00753818.

Source: Am J Clin Nutr 91: 848-859, 2010

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