Chronic and Acute Effects of Artificial Colourings and Preservatives on Children's Behaviour

ISRCTN	ISRCTN74481308
DOI	https://doi.org/10.1186/ISRCTN74481308
Protocol serial number	pwh/ab/16/1/2491
Sponsor	University of Southampton (UK)
Funder	Food Standards Agency (UK) (Grant T07040)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Jim Stevenson
Scientific

School of Psychology
University of Southampton
Highfield
Southampton
SO17 1BJ
United Kingdom

Phone	+44 (0)23 8059 2583
Email	jsteven@soton.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	FABiC - Food And Behaviour in Children
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Artificial food colourings and preservatives (AFCPs)
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
Key secondary outcome measure(s)	Sleep
Completion date	28/02/2007

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Upper age limit	8 Years
Sex	All
Target sample size at registration	297
Key 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.
Key exclusion criteria	Those on special diets.
Date of first enrolment	01/03/2005
Date of final enrolment	28/02/2007

School of Psychology

Southampton
SO17 1BJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	03/11/2007		Yes	No