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ISRCTN
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ISRCTN56149264
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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ADICBID
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Serial number at source
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SGUL/SWLSG 001
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Study hypothesis
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Dietary intervention using multivitamins is able to reduce challenging behaviour in a learning disabled adult population.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Challenging behaviour in an intellectualy disabled population
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/10/2006
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Anticipated end date
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01/10/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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200 (100 per group)
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Interventions
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Active multivitamin compound versus placebo.
Please note that as of 17/09/2007 this trial was put on hold due to funding issues.
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Primary outcome measure(s)
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Reduction in frequency and intensity of challenging behaviours
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Secondary outcome measure(s)
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Improvements to quality of life and social functioning
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Sources of funding
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No funding as of 17/09/2007
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Trial website
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Publications
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Contact name
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Prof
Sheila
Hollins
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Address
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Division of Mental Health, Social and Developmental Psychiatry
St George's
Cranmer Terrace
Tooting
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City/town
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London
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Zip/Postcode
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SW17 0RE
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Country
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United Kingdom
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Tel
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+44 (0)208 725 5501
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Email
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shollins@sgul.ac.uk
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Sponsor
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St George's, University of London (UK)
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Address
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Cranmer Terrace
Tooting
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City/town
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London
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Zip/Postcode
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SW17 0RE
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Country
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United Kingdom
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Tel
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+44 (0)208 672 9944
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Email
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rmukherj@sgul.ac.uk
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Sponsor website:
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http://www.sgul.ac.uk
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Date applied
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06/09/2005
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Last edited
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05/01/2012
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Date ISRCTN assigned
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07/10/2005
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