Do Food Additives cause hyperactivity and Behavioural problems in a population of three year olds?
| ISRCTN | ISRCTN13645495 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13645495 |
| Protocol serial number | SPGS803 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South East (UK) |
- 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
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 |
|---|---|
| belinda.bateman@lineone.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| 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(s) |
Measurement of hyperactivity and behavioural problems. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 1873 |
| 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
- United Kingdom
- England
Study participating centre
The David Hide Asthma and Allergy Research Centre
Newport
PO30 5TG
United Kingdom
PO30 5TG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
