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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

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
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.
0140-6736
1560-1567
McCann, Donna
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Barrett, Angelina
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Cooper, Alison
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Crumpler, Debbie
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Dalen, Lindy
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Grimshaw, Kate
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Kitchin, Elizabeth
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Lok, Kris
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Porteous, Lucy
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Prince, Emily
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Sonuga-Barke, Edmund
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Warner, John O.
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Stevenson, Jim
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McCann, Donna
8c5e4455-018a-475e-a2e3-3faca15f7ddf
Barrett, Angelina
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Cooper, Alison
b19ba749-723b-48e0-8bef-bfbeaccdf9f0
Crumpler, Debbie
1f288090-6878-496c-91f7-8224e9277d32
Dalen, Lindy
5b141133-08f6-4025-afa3-47275cbe1d56
Grimshaw, Kate
766b6cf0-347a-447d-aeab-f07366f8ce28
Kitchin, Elizabeth
2edaa8c4-6f44-450a-a625-75c3546f71aa
Lok, Kris
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Porteous, Lucy
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Prince, Emily
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Sonuga-Barke, Edmund
bc80bf95-6cf9-4c76-a09d-eaaf0b717635
Warner, John O.
50630e99-8486-4859-ade3-cd2c79c5a153
Stevenson, Jim
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McCann, Donna, Barrett, Angelina, Cooper, Alison, Crumpler, Debbie, Dalen, Lindy, Grimshaw, Kate, Kitchin, Elizabeth, Lok, Kris, Porteous, Lucy, Prince, Emily, Sonuga-Barke, Edmund, Warner, John O. and Stevenson, Jim (2007) 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. The Lancet, 370 (9598), 1560-1567. (doi:10.1016/S0140-6736(07)61306-3).

Record type: Article

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.

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.

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Published date: 3 November 2007
Organisations: Psychology

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Local EPrints ID: 145999
URI: http://eprints.soton.ac.uk/id/eprint/145999
ISSN: 0140-6736
PURE UUID: 317a1706-9260-4aec-aa81-757243a19132

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Date deposited: 03 Jun 2010 10:25
Last modified: 16 Dec 2019 20:53

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Contributors

Author: Donna McCann
Author: Angelina Barrett
Author: Alison Cooper
Author: Debbie Crumpler
Author: Lindy Dalen
Author: Kate Grimshaw
Author: Elizabeth Kitchin
Author: Kris Lok
Author: Lucy Porteous
Author: Emily Prince
Author: Edmund Sonuga-Barke
Author: John O. Warner
Author: Jim Stevenson

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