School Nutrition to Improve Behaviour

ISRCTN	ISRCTN03817376
DOI	https://doi.org/10.1186/ISRCTN03817376
Secondary identifying numbers	RCSP3

Submission date: 13/04/2010
Registration date: 07/06/2010
Last edited: 12/12/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof John Stein
Scientific

Physiology Department
Sherrington Building
Parks Road
Oxford
OX1 3PT
United Kingdom

ORCID ID	0000-0001-5843-8986
Phone	+44 (0)1865 272552
Email	john.stein@dpag.ox.ac.uk

Study information

Study design	Double-blind randomised placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	School
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	Nutritional supplements to improve disadvantaged pupils' cognitive skills and behaviour: a double-blind randomised placebo-controlled trial
Study acronym	SNIB
Study objectives	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(s)	South West Research Ethics Committee pending as of 13/04/2010 (ref: 10/HO206/13)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/2010
Completion date	30/11/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	14 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	200
Key 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
Key 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
Date of first enrolment	01/05/2010
Date of final enrolment	30/11/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Oxford

Oxford
OX1 3PT
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

Clinical Trials and Research Governance
Rm 8, Manor House
Oxford
OX3 9DZ
England
United Kingdom

Phone	+44 (0)1865 222757
Email	heather.house@admin.ox.ac.uk
Website	http://www.ox.ac.uk/
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Charity

Esmee Fairbairn Trust (UK) (ref: 09-2343)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	To be confirmed at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/01/2016		Yes	No

Editorial Notes

12/12/2017: Publication reference added.