title: 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.
abstract: 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: School of Psychology, Department of Child Health, University of Southampton, Southampton, UK.
authors.forename: Donna
authors.initials: D
authors.lastname: McCann
authors.forename: Angelina
authors.initials: A
authors.lastname: Barrett
authors.forename: Alison
authors.initials: A
authors.lastname: Cooper
authors.forename: Debbie
authors.initials: D
authors.lastname: Crumpler
authors.forename: Lindy
authors.initials: L
authors.lastname: Dalen
authors.forename: Kate
authors.initials: K
authors.lastname: Grimshaw
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Kitchin
authors.forename: Kris
authors.initials: K
authors.lastname: Lok
authors.forename: Lucy
authors.initials: L
authors.lastname: Porteous
authors.forename: Emily
authors.initials: E
authors.lastname: Prince
authors.forename: Edmund
authors.initials: E
authors.lastname: Sonuga-Barke
authors.forename: John O
authors.initials: JO
authors.lastname: Warner
authors.forename: Jim
authors.initials: J
authors.lastname: Stevenson
mesh_terms: D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005190:Family; D005260:Female; D005505:Food Coloring Agents / Q000008:administration & dosage / Q000009:adverse effects*; D005520:Food Preservatives / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D006948:Hyperkinesis / Q000139:chemically induced*; D008297:Male; D020160:Sodium Benzoate / Q000008:administration & dosage / Q000009:adverse effects*