We undertook a randomised, double-blinded, placebo-controlled, crossover trial to test whether intake of artificial food colour and additives (AFCA) affected childhood behaviour.
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 behaviours and ratings by teachers and parents, plus, for 8/9-year-old children, a computerised test of attention. This clinical trial is registered with Current Controlled Trials (registration number ISRCTN74481308). Analysis was per protocol.
16 3-year-old children and 14 8/9-year-old children did not complete the study, for reasons unrelated to childhood behaviour. 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.
Artificial colours 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.
l McCann D, Barrett A, Cooper A, et al. Food additives and hyperactive behavior in 3-year-old and 8/9-year-old children in the community: a randomized, double-blinded, placebo-controlled trial. The Lancet; 2007: 370:9598,1560-1567.
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