| 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.
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.
Affiliations
a. School of Psychology, Department of Child
Health, University of Southampton, Southampton, UK
b. School of Medicine, Department of Child
Health, University of Southampton, Southampton, UK
c. Department of Paediatrics, Imperial
College, London, UK
Corresponding Author InformationCorrespondence
to: Prof Jim Stevenson, School of Psychology, Faculty of Medicine,
Health and Life Sciences, University of Southampton, Southampton
SO17 1BJ, UK
Summary and full text available at http://www.thelancet.com/journals/lancet/article/PIIS0140673607613063/abstract. |
