Contact information
Type
Scientific
Primary contact
Dr Belinda Bateman
ORCID ID
Contact details
The David Hide Asthma and Allergy Research Centre
St Mary's Hospital
Isle of Wight
Newport
PO30 5TG
United Kingdom
+44 (0)1983 534113
belinda.bateman@lineone.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SPGS803
Study information
Scientific title
Acronym
FAB
Study hypothesis
Do artificial food colourings and the preservative sodium benzoate affect the behaviour and activity levels of a geographically defined group of three year olds?
Secondary Questions:
1. What is the prevalence of hyperactivity and behavioural problems in a geographically defined group of three year olds?
2. What is the prevalence of atopy and allergic symptoms in a geographically defined group of three year olds?
3. To what extent do parents believe that their child's behaviour is affected by food and drink?
4. Does being atopic or hyperactive make the child's behaviour susceptible in any way to artificial food colourings and the preservative sodium benzoate?
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
Other
Trial type
Other
Patient information sheet
Condition
Mental and behavioural disorders
Intervention
1. Active drink
2. Placebo
The active drink contains 20 mg total artificial food colourings (sunset yellow, tartrazine, carmoisine and ponceau 4R) and 45 mg of sodium benzoate.
Intervention type
Drug
Phase
Not Specified
Drug names
'Active drink' (contains 20 mg total artificial food colourings [sunset yellow, tartrazine, carmoisine and ponceau 4R] and 45 mg of sodium benzoate)
Primary outcome measures
Measurement of hyperactivity and behavioural problems.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/1999
Overall trial end date
01/03/2000
Reason abandoned
Eligibility
Participant inclusion criteria
Children on the Isle of Wight born between 01/09/1994 and 31/08/1996.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1873 (added 17/09/10; see publication)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/07/1999
Recruitment end date
01/03/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The David Hide Asthma and Allergy Research Centre
Newport
PO30 5TG
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South East (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15155391
Publication citations
-
Results
Bateman B, Warner JO, Hutchinson E, Dean T, Rowlandson P, Gant C, Grundy J, Fitzgerald C, Stevenson J, The effects of a double blind, placebo controlled, artificial food colourings and benzoate preservative challenge on hyperactivity in a general population sample of preschool children., Arch. Dis. Child., 2004, 89, 6, 506-511.