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Adjunctive Dietary Intervention study for Challenging Behaviour in people with an Intellectual Disability: a randomised double blind placebo controlled multicentre clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN56149264
Enrollment
200
Registered
2005-10-07
Start date
2006-10-01
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

Challenging behaviour in an intellectualy disabled population Mental and Behavioural Disorders Mental retardation

Interventions

Active multivitamin compound versus placebo. Please note that as of 17/09/2007 this trial was put on hold due to funding issues.

Sponsors

St George's, University of London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. People aged between 18 and 70 2. People with a learning disability able to show consent or assent to inclusion 3. Challenging behaviour with a frequency averaging at least once a month in the three months prior to admission to the study 4. Existing medication usage will be allowed during the trial. There is no need to stop or change medication that the client is already taking. 5. The person must be living in a setting where there is help to fill in diaries and someone from whom objective reports are available. This will include family, residential homes or inpatient centres

Exclusion criteria

Exclusion criteria: 1. Explicit refusal to participate 2. Living independently 3. Acute Mental Illness (chronic stable mental illness is allowed) 4. Full autism diagnosis (this does not include single autistic features without the full diagnosis) 5. Vegetarian 6. Allergy to vitamins or fish oils

Design outcomes

Primary

MeasureTime frame
Reduction in frequency and intensity of challenging behaviours

Secondary

MeasureTime frame
Improvements to quality of life and social functioning

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026