Condition category
Mental and Behavioural Disorders
Date applied
06/09/2005
Date assigned
07/10/2005
Last edited
09/03/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.sgul.ac.uk

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

Publication citations

Additional files

Editorial Notes