The Middlesbrough study: a randomised, controlled trial of dietary supplements with omega-3/omega-6 fatty acids in mainstream school children

ISRCTN ISRCTN12286781
DOI https://doi.org/10.1186/ISRCTN12286781
Secondary identifying numbers DCC-RCT-MIDD-00001
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
01/11/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
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

Contact information

Dr Madeleine Portwood
Scientific

Education Development Centre
Enterprise Way
Spennymoor
DL16 6JE
United Kingdom

Phone +44 (0)1388 424 901

Study information

Study designInterventional, multi-centre, randomised double-blind, placebo controlled, one-way crossover study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Scientific title
Study objectivesOmega-3 consumption in children in western Countries has been declining. At the same time there has been concerns about the increased levels of poor concentration, hyperactivity and learning difficulties evidenced in the UK school population. Of these children a proportion (30%) do not appear to respond to standard interventions and a large proportion were found to have eczema, asthma, lactose intolerance and other allergies that may be related to dietary deficiencies. The focus of this study is to determine the effect of dietary intervention on learning and behavioural conditions.

Previous Randomised Controlled Trials (RCTs) have indicated a positive effect on reducing hyperactivity and improved educational attainment in children with specific learning difficulties (Dyslexia/Developmental Coordination Disorder [Dyspraxia] and Attention Deficit Hyperactivity Disorder [ADHD]) following dietary supplementation with omega-3/omega-6 fatty acids. This trial will test the hypothesis that similar effects are evident with dietary omega-3/omega-6 supplementation in a cross-section of mainstream schoolchildren, who do not have diagnosed learning difficulties/behavioural problems.
Ethics approval(s)Approval was sought in March 2005 from South Tees Local Research Ethics Committee. At that time, the committee stated "This study does not fall within Section 3 of Governance Arrangements for Research Ethics Committees (GAfREC), which identifies that ethical advice from the appropriate NHS REC is required for any research involving activities within Section 3.1 a-g".

The committee were asked to review their decision and their response has been:

"In accordance with Section 1.88 of the Standard Operating Procedures for Research Ethics Committees (SOPs), I have been asked to review the file and to comment. I have been asked for my opinion as Chair of County Durham and Tees Valley 1 REC. I was Chair of South Tees LREC in April 2005.

"If submitted for full review by the LREC, it must be judged by the standard and requirements at the time, that is Spring 2005. This project is an extension of previous work, but in this case specifically looking to recruit a different child population, including children that were educationally underachieving.

"The research team and facilities were appropriate. The only identified risk was a minimal risk of mild digestive upset with a reported rate of 3%. Standard psychometric assessments were proposed. Children were randomly allocated to the active or a placebo supplement and the researchers were 'blinded' to the allocation.

"The welfare of all the participants was appropriately safeguarded and the exclusion criteria sensible.

"The provision of information to the school staff, general practitioners, parents and children were satisfactory and consent dealt with appropriately. In my view, the Committee at that time would have given a 'favourable' opinion."
Health condition(s) or problem(s) studiedPoor concentration, hyperactivity, learning abilities and working memory
InterventionActive treatment: dietary supplement (Eye q):
Omega-3/omega-6 dietary supplement in capsule form, six times/day providing 558 mg Eicosapentaenoic Acid (EPA), 174 mg Docosahexaenoic Acid (DHA), 60 mg Gamma Linolenic Acid for duration of trial.

Control group: dietary supplement (placebo):
Placebo containing medium-chain triglycerides derived from olive oil, 4% of the capsule comprised EPA and DHA to ensure a fishy taste and carrot oil macerate for colouring. After three months this group crossed over to the active treatment.

The duration of the treatment was six months (one-way crossover from placebo to active after three months) with staggered entry over two months. Assessments for primary/secondary outcome measures were completed at baseline, three and six months. A random sample of 50 participants will be tracked until they leave school, aged 16/18. Follow up will involve monitoring participants' attainments in National Tests (KS 1, 2 and 3 results and performance at KS4 via GCSE/Vocational qualifications).
Intervention typeSupplement
Primary outcome measure1. Measurement of change in working memory, confirmed by results from Wechsler Intelligence Scale for Children (WISC-III UK) digit span assessment; time frame: 6 months
2. Measurement of change in reading ability, using the Wechsler Objective Reading Dimensions (WORD) assessment; time frame: 6 months
Secondary outcome measures1. Measuring a range of behavioural parameters including cognitive problems, hyperactivity, social problems, ADHD and emotional lability as identified by parents using the Conners' Parent Rating Scales-Long Version (CPRS-L); time frame: 6 months
2. Measuring a range of behavioural parameters including cognitive problems, hyperactivity, social problems, ADHD and emotional lability as identified by teachers using the Conners' Teacher Rating Scales-Long Version (CTRS-L); time frame: 6 months
Overall study start date01/04/2005
Completion date31/01/2006

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants250
Key inclusion criteriaParticipants attend mainstream school.
Key exclusion criteriaChildren with:
1. Significant neurological problems
2. Psychiatric conditions
3. Any of the following medical problems:
3.1. Epilepsy
3.2. Cerebral palsy
3.3. Multiple sclerosis
3.4. Myalgic encephalopathy
3.5. Pervasive developmental disorder
3.6. Autism
4. Diagnosed ADHD
5. Consumption of essential fatty-acid supplementation within previous three months
Date of first enrolment01/04/2005
Date of final enrolment31/01/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Education Development Centre
Spennymoor
DL16 6JE
United Kingdom

Sponsor information

Durham County Council (UK)
Government

County Hall
Durham
DH1 5UJ
United Kingdom

Phone +44 (0)191 383 000
Website http://www.durham.gov.uk/
ROR logo "ROR" https://ror.org/05btx4z39

Funders

Funder type

Government

Middlesbrough Council (UK) - funding

No information available

Durham County Council (UK) - funding

No information available

Equazen Ltd (UK) - provided active and placebo treatments

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan