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Background
We undertook a randomized, double-blinded, placebo-controlled, crossover trial to test whether intake of artificial food color and additives (AFCA) affected childhood behavior.
Methods
153 3-year-old and 144 8/9-year-old children were included in the study. The challenge drink contained sodium benzoate and one of two AFCA mixes (A or B) or a placebo mix. The main outcome measure was a global hyperactivity aggregate (GHA), based on aggregated z-scores of observed behaviors and ratings by teachers and parents, plus, for 8/9-year-old children, a computerized test of attention. This clinical trial is registered with Current Controlled Trials (registration number ISRCTN74481308). Analysis was per protocol.
Findings
16 3-year-old children and 14 8/9-year-old children did not complete the study, for reasons unrelated to childhood behavior. Mix A had a significantly adverse effect compared with placebo in GHA for all 3-year-old children (effect size 0·20 [95% CI 0·01–0·39], p=0·044) but not mix B versus placebo. This result persisted when analysis was restricted to 3-year-old children who consumed more than 85% of juice and had no missing data (0·32 [0·05–0·60], p=0·02). 8/9-year-old children showed a significantly adverse effect when given mix A (0·12 [0·02–0·23], p=0·023) or mix B (0·17 [0·07–0·28], p=0·001) when analysis was restricted to those children consuming at least 85% of drinks with no missing data.
Interpretation
Artificial colors or a sodium benzoate preservative (or both) in the diet result in increased hyperactivity in 3-year-old and 8/9-year-old children in the general population.
Affiliations
a. School of Psychology, Department of Child Health, University of Southampton, Southampton, UK
b. School of Medicine, Department of Child Health, University of Southampton, Southampton, UK
c. Department of Paediatrics, Imperial College, London, UK
