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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74481308
Enrollment
297
Registered
2005-08-02
Start date
2005-03-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperactivity Mental and Behavioural Disorders Hyperactivity

Interventions

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

Sponsors

University of Southampton (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Those on special diets.

Design outcomes

Primary

MeasureTime frame
1. Direct observation of classroom behaviour 2. Parent and teacher ratings of hyperactive behaviour 3. Continuous performance test assessment of sustained attention

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026