Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
17/09/2010
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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes