Lancet. 2007 Nov 3;370(9598):1560-7.
Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community:
a randomised, double-blinded, placebo-controlled trial.Donna McCann, Angelina Barrett, Alison Cooper, Debbie Crumpler, Lindy Dalen, Kate Grimshaw, Elizabeth Kitchin,
Kris Lok, Lucy Porteous, Emily Prince, Edmund Sonuga-Barke, John O Warner and Jim Stevenson
Background: We undertook a randomised, double-blinded, placebo-controlled, crossover trial to test whether intake of artificial food colour and additives (AFCA) affected childhood behaviour. 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 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. Findings: 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. Interpretation: 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.