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.
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.
McCann
Donna
D
School of Psychology, Department of Child Health, University of Southampton, Southampton, UK.
Barrett
Angelina
A
Cooper
Alison
A
Crumpler
Debbie
D
Dalen
Lindy
L
Grimshaw
Kate
K
Kitchin
Elizabeth
E
Lok
Kris
K
Porteous
Lucy
L
Prince
Emily
E
Sonuga-Barke
Edmund
E
Warner
John O
JO
Stevenson
Jim
J
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*