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 |
| Protocol serial number | DCC-RCT-MIDD-00001 |
| Sponsor | Durham County Council (UK) |
| Funders | Middlesbrough Council (UK) - funding, Durham County Council (UK) - funding, Equazen Ltd (UK) - provided active and placebo treatments |
- 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
Scientific
Education Development Centre
Enterprise Way
Spennymoor
DL16 6JE
United Kingdom
| Phone | +44 (0)1388 424 901 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional, multi-centre, randomised double-blind, placebo controlled, one-way crossover study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 250 |
| Key inclusion criteria | Participants attend mainstream school. |
| Key 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 |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 31/01/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Education Development Centre
Spennymoor
DL16 6JE
United Kingdom
DL16 6JE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
