Condition category
Mental and Behavioural Disorders
Date applied
18/07/2005
Date assigned
02/08/2005
Last edited
07/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jim Stevenson

ORCID ID

Contact details

School of Psychology
University of Southampton
Highfield
Southampton
SO17 1BJ
United Kingdom
+44 (0)23 8059 2583
jsteven@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

pwh/ab/16/1/2491

Study information

Scientific title

Acronym

FABiC - Food And Behaviour in Children

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?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Hyperactivity

Intervention

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

Intervention type

Drug

Phase

Not Specified

Drug names

Artificial food colourings and preservatives (AFCPs)

Primary outcome measures

1. Direct observation of classroom behaviour
2. Parent and teacher ratings of hyperactive behaviour
3. Continuous performance test assessment of sustained attention

Secondary outcome measures

Sleep

Overall trial start date

01/03/2005

Overall trial end date

28/02/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

153 3 year-olds and 144 8/9 year-olds

Participant exclusion criteria

Those on special diets.

Recruitment start date

01/03/2005

Recruitment end date

28/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Psychology
Southampton
SO17 1BJ
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

Research Support Office
University of Southampton
Highfield
Southampton
SO17 1BJ
United Kingdom
+44 (0)23 8059 8672
info@rso.soton.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Food Standards Agency (UK) (Grant T07040)

Alternative name(s)

FSA

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17825405

Publication citations

  1. Results

    McCann D, Barrett A, Cooper A, Crumpler D, Dalen L, Grimshaw K, Kitchin E, Lok K, Porteous L, Prince E, Sonuga-Barke E, Warner JO, Stevenson J, 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., Lancet, 2007, 370, 9598, 1560-1567, doi: 10.1016/S0140-6736(07)61306-3.

Additional files

Editorial Notes