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Chronic and Acute Effects of Artificial Colourings and Preservatives on Children's Behaviour
ISRCTN ISRCTN74481308
DOI 10.1186/ISRCTN74481308
ClinicalTrials.gov identifier
EudraCT number
Public title Chronic and Acute Effects of Artificial Colourings and Preservatives on Children's Behaviour
Scientific title
Acronym FABiC - Food And Behaviour in Children
Serial number at source pwh/ab/16/1/2491
Study hypothesis 1. Do children show a behavioural response to the withdrawal and introduction of artificial food colourings and preservatives (AFCPs)?
2. What are the characteristics that differentiate responders to AFCPs and non-responders baseline attention deficit hyperactivity disorder (ADHD) symptom severity and/or their genotype?
3. Can any response that is found in the stage one trial be replicated in a blind acute challenge?
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Hyperactivity
Participants - inclusion criteria Stage 1 - Chronic exposure - 120 three year old children and 120 eight year old children from the general population.
Stage 2 - Acute exposure - 45 eight year old children selected as being responders or non-responders in the Stage 1 challenge.
Participants - exclusion criteria Those on special diets.
Anticipated start date 01/03/2005
Anticipated end date 28/02/2007
Status of trial Completed
Patient information material
Target number of participants 153 3 year-olds and 144 8/9 year-olds
Interventions A within subject double blind food challenge exposure to two additive mixes and one placebo mix - all children receiving all mixtures in a randomised order
Primary outcome measure(s) 1. Direct observation of classroom behaviour
2. Parent and teacher ratings of hyperactive behaviour
3. Continuous performance test assessment of sustained attention
Secondary outcome measure(s) Sleep
Sources of funding Food Standards Agency (UK) (Grant T07040)
Trial website
Publications Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17825405
Contact name Prof  Jim  Stevenson
  Address School of Psychology
University of Southampton
Highfield
  City/town Southampton
  Zip/Postcode SO17 1BJ
  Country United Kingdom
  Tel +44 (0)23 8059 2583
  Fax +44 (0)23 8059 4719
  Email jsteven@soton.ac.uk
Sponsor University of Southampton (UK)
  Address Research Support Office
University of Southampton
Highfield
  City/town Southampton
  Zip/Postcode SO17 1BJ
  Country United Kingdom
  Tel +44 (0)23 8059 8672
  Fax +44 (0)23 8059 8671
  Email info@rso.soton.ac.uk
Date applied 18/07/2005
Last edited 07/12/2007
Date ISRCTN assigned 02/08/2005
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