| 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. |
