The Lancet 2007 (Nov); 370 (9598): 1560–1567
Donna McCann PhD, Angelina Barrett BSc, Alison Cooper MSc, Debbie Crumpler BSc,
Lindy Dalen PhD, Kate Grimshaw MSc, Elizabeth Kitchin BSc, Kris Lok MSc,
Lucy Porteous BSc, Emily Prince MSc, Prof Edmund Sonuga-Barke PhD,
Prof John O Warner MD, and Prof Jim Stevenson PhD
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.
School of Psychology, Department of Child Health, University of Southampton, Southampton, UK
School of Medicine, Department of Child Health, University of Southampton, Southampton, UK
Department of Paediatrics, Imperial College, London, UK
Correspondence to: Prof Jim Stevenson, School of Psychology, Faculty of Medicine, Health and Life Sciences, University of Southampton, Southampton SO17 1BJ, UK
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