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

ISRCTN	ISRCTN56149264
DOI	https://doi.org/10.1186/ISRCTN56149264
Secondary identifying numbers	SGUL/SWLSG 001

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Sheila Hollins
Scientific

Division of Mental Health, Social and Developmental Psychiatry
St George's
Cranmer Terrace
Tooting
London
SW17 0RE
United Kingdom

Phone	+44 (0)208 725 5501
Email	shollins@sgul.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Adjunctive Dietary Intervention study for Challenging Behaviour in people with an Intellectual Disability: a randomised double blind placebo controlled multicentre clinical trial
Study acronym	ADICBID
Study objectives	Dietary intervention using multivitamins is able to reduce challenging behaviour in a learning disabled adult population.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure	Reduction in frequency and intensity of challenging behaviours
Secondary outcome measures	Improvements to quality of life and social functioning
Overall study start date	01/10/2006
Completion date	01/10/2008
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200 (100 per group)
Key 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
Key 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
Date of first enrolment	01/10/2006
Date of final enrolment	01/10/2008

St George's, University of London

London
SW17 0RE
United Kingdom

St George's, University of London (UK)
University/education

Cranmer Terrace
Tooting
London
SW17 0RE
England
United Kingdom

Other

No funding as of 17/09/2007

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan