Plain English Summary
Background and study aims
A lack of long-chain omega 3 fatty acids, vitamins and minerals in the diet has been linked to antisocial behavior; correcting such deficiencies may therefore improve children's behaviour. We aimed to test the effects on behaviour of omega 3, mineral and vitamin supplements in UK adolescents.
Who can participate?
All year 10 pupils (male and female, aged 14 - 16 years) in the Robert Clack School will be asked to volunteer for the study.
What does the study involve?
Participants are randomly allocated to take either capsules containing the recommended intake of vitamins, minerals and omega 3 fatty acids, or identical looking and tasting placebo capsules, for 3 months. Blood samples are taken before and after supplementation and any changes in behaviour are measured using teacher rating scales together with school disciplinary records.
What are the possible benefits and risks of participating?
Participants' behaviour may improve. There are minimal risks.
Where is the study run from?
University of Oxford (UK).
When is the study starting and how long is it expected to run for?
May 2010 to November 2011.
Who is funding the study?
Esmee Fairbairn Trust (UK)
Who is the main contact?
Prof John Stein
john.stein@dpag.ox.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof John Stein
ORCID ID
http://orcid.org/0000-0001-5843-8986
Contact details
Physiology Department
Sherrington Building
Parks Road
Oxford
OX1 3PT
United Kingdom
+44 (0)1865 272552
john.stein@dpag.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RCSP3
Study information
Scientific title
Nutritional supplements to improve disadvantaged pupils' cognitive skills and behaviour: a double-blind randomised placebo-controlled trial
Acronym
SNIB
Study hypothesis
Can supplementation with capsules of vitamins, minerals and omega 3 fatty acids designed to bring levels up to recommended daily intakes significantly improve disadvantaged pupils' antisocial behaviour?
Ethics approval
South West Research Ethics Committee pending as of 13/04/2010 (ref: 10/HO206/13)
Study design
Double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Schools
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nutrition/antisocial behaviour
Intervention
3 months administration of capsules containing recommended intake of vitamins, minerals (1 capsule) and omega 3 fatty acids (2 capsules) or identical looking and tasting placebo capsules. Follow-up is for 3 months.
Intervention type
Supplement
Phase
Not Specified
Drug names
Vitamins, minerals, omega 3 fatty acids
Primary outcome measures
Current primary outcome measure(s) as of 24/04/2012
Offences against disciplinary rules, recorded by the School Pupil Referral Unit and Learning Support Centre and other school discipline databases
Measured at:
Time 1: in the 12 weeks prior to randomisation
Previous primary outcome measure(s)
Offences against disciplinary rules, recorded by the School Pupil Referral Unit and Learning Support Centre
Measured at:
Time 1: week 0, before randomisation
Time 2: last week (12) of intervention
Secondary outcome measures
Current secondary outcome measure(s) as of 24/04/2012
1. Computerised measurements of changes in cognitive skills: reading spelling, short term memory, nonverbal intelligence, Teacher ADHD assessments.
2. Correlation of disciplinary and cognitive changes with changes in nutrient blood levels irrespective of whether allocated active or placebo
Previous secondary outcome measure(s)
1. Computerised measurements of cognitive skills: reading, spelling, mathematics, rapid visual processing, attention, impulsivity
2. Correlation of changes in participants' blood levels of essential micronutrients with changes in cognitive skills and antisocial behaviour
Measured at:
Time 1: week 0, before randomisation
Time 2: last week (12) of intervention
Overall trial start date
01/05/2010
Overall trial end date
30/11/2011
Reason abandoned
Eligibility
Participant inclusion criteria
All year 10 pupils (male and female, aged 14 - 16 years) in the Robert Clack School will be asked to volunteer for the study
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Major medical disorders
2. Taking psychoactive medications expected to affect behaviour and learning
3. Taking vitamin supplements or fish oils already, or eating fish greater than 2 x week
4. Poor English
Recruitment start date
01/05/2010
Recruitment end date
30/11/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Oxford
Oxford
OX1 3PT
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Clinical Trials and Research Governance
Rm 8
Manor House
Oxford
OX3 9DZ
United Kingdom
+44 (0)1865 222757
heather.house@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Esmee Fairbairn Trust (UK) (ref: 09-2343)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary