Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
01/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Madeleine Portwood

ORCID ID

Contact details

Education Development Centre
Enterprise Way
Spennymoor
DL16 6JE
United Kingdom
+44 (0)1388 424 901

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DCC-RCT-MIDD-00001

Study information

Scientific title

Acronym

Study hypothesis

Omega-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

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."

Study design

Interventional, multi-centre, randomised double-blind, placebo controlled, one-way crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Poor concentration, hyperactivity, learning abilities and working memory

Intervention

Active 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 type

Supplement

Phase

Not Applicable

Drug names

Omega-3/omega-6 supplements (including Eicosapentaenoic Acid, Docosahexaenoic Acid, Gamma Linolenic Acid)

Primary outcome measures

1. 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 measures

1. 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 trial start date

01/04/2005

Overall trial end date

31/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Participants attend mainstream school.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

250

Participant exclusion criteria

Children 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

Recruitment start date

01/04/2005

Recruitment end date

31/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Education Development Centre
Spennymoor
DL16 6JE
United Kingdom

Sponsor information

Organisation

Durham County Council (UK)

Sponsor details

County Hall
Durham
DH1 5UJ
United Kingdom
+44 (0)191 383 000

Sponsor type

Government

Website

http://www.durham.gov.uk/

Funders

Funder type

Government

Funder name

Middlesbrough Council (UK) - funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Durham County Council (UK) - funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Equazen Ltd (UK) - provided active and placebo treatments

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