Contact information
Type
Scientific
Primary contact
Prof Sheila Hollins
ORCID ID
Contact details
Division of Mental Health
Social and Developmental Psychiatry
St George's
Cranmer Terrace
Tooting
London
SW17 0RE
United Kingdom
+44 (0)208 725 5501
shollins@sgul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SGUL/SWLSG 001
Study information
Scientific title
Adjunctive Dietary Intervention study for Challenging Behaviour in people with an Intellectual Disability: a randomised double blind placebo controlled multicentre clinical trial
Acronym
ADICBID
Study hypothesis
Dietary intervention using multivitamins is able to reduce challenging behaviour in a learning disabled adult population.
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
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Challenging behaviour in an intellectually disabled population
Intervention
Active multivitamin compound versus placebo.
Please note that as of 17/09/2007 this trial was put on hold due to funding issues.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Reduction in frequency and intensity of challenging behaviours
Secondary outcome measures
Improvements to quality of life and social functioning
Overall trial start date
01/10/2006
Overall trial end date
01/10/2008
Reason abandoned
Lack of funding/sponsorship
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200 (100 per group)
Participant 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
Recruitment start date
01/10/2006
Recruitment end date
01/10/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St George's, University of London
London
SW17 0RE
United Kingdom
Sponsor information
Organisation
St George's, University of London (UK)
Sponsor details
Cranmer Terrace
Tooting
London
SW17 0RE
United Kingdom
+44 (0)208 672 9944
rmukherj@sgul.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
No funding as of 17/09/2007
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