Do Food Additives cause hyperactivity and Behavioural problems in a population of three year olds?

ISRCTN	ISRCTN13645495
DOI	https://doi.org/10.1186/ISRCTN13645495
Secondary identifying numbers	SPGS803

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 17/09/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Belinda Bateman
Scientific

The David Hide Asthma and Allergy Research Centre
St Mary's Hospital
Isle of Wight
Newport
PO30 5TG
United Kingdom

Phone	+44 (0)1983 534113
Email	belinda.bateman@lineone.net

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Other
Scientific title
Study acronym	FAB
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	'Active drink' (contains 20 mg total artificial food colourings [sunset yellow, tartrazine, carmoisine and ponceau 4R] and 45 mg of sodium benzoate)
Primary outcome measure	Measurement of hyperactivity and behavioural problems.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/07/1999
Completion date	01/03/2000

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	1873 (added 17/09/10; see publication)
Key inclusion criteria	Children on the Isle of Wight born between 01/09/1994 and 31/08/1996.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/07/1999
Date of final enrolment	01/03/2000

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The David Hide Asthma and Allergy Research Centre

Newport
PO30 5TG
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South East (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2004		Yes	No