Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/04/2010
Date assigned
07/06/2010
Last edited
07/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.ox.ac.uk/

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

Publication citations

Additional files

Editorial Notes