ISRCTN48803273 - The DHA (docosahexaenoic acid) Oxford Learning and Behaviour [DOLAB II) Study: Does taking an Omega 3 food supplement help children’s learning and behaviour?

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21 March 2013

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The DHA (docosahexaenoic acid) Oxford Learning and Behaviour [DOLAB II) Study: Does taking an Omega 3 food supplement help children’s learning and behaviour?

ISRCTN	ISRCTN48803273
DOI	10.1186/ISRCTN48803273
ClinicalTrials.gov identifier
EudraCT number
Public title	The DHA (docosahexaenoic acid) Oxford Learning and Behaviour [DOLAB II) Study: Does taking an Omega 3 food supplement help children’s learning and behaviour?
Scientific title	The DHA (docosahexaenoic acid) Oxford Learning and Behaviour Study (DOLAB II): A randomised double blind controlled study measuring the effect of DHA on children's reading ability, cognition and behaviour
Acronym	DOLAB II
Serial number at source	12/SC/0465
Study hypothesis	We hypothesise that docosahexaneoic acid (DHA) (in a daily dose of 600 mg) will improve the behaviour and learning of normal children aged 7 - 9 years in mainstream state schools who are under performing in reading according to nationally standardised tests.
Lay summary	Background and study aims UK children’s diets are low in the long-chain omega-3 fatty acid DHA (docosahexaenoic acid), essential for mental and physical health. Small trials involving children with conditions like Attention deficit-hyperactivity disorder (ADHD), dyslexia or other behaviour and/or learning difficulties have indicated that increased intakes of long-chain omega-3 (found naturally in fish, seafood and some algae) can improve their behaviour and learning, raising the possibility that similar benefits might extend to children from the general school population. A trial involving children aged 7-9 years from mainstream schools (known as the DHA Oxford Learning and Behaviour (DOLAB) study) was recently completed by this research team at Oxford University. Results showed that dietary supplementation with 600mg/day of DHA for 16 weeks led to significant benefits for reading progress in poorer readers when compared with a placebo (dummy), with no negative side-effects. Significant improvements were also reported by parents in the children’s behaviour (attention, concentration and hyperactivity-impulsivity). Additional findings revealed that blood concentrations of DHA in these healthy children were low by comparison with recommendations for general health in adults, and were also directly related to their performance in reading, working memory and behaviour. This new study is designed to see if these results can be replicated. If so, the implications would be profound since there is an urgent need for safe, effective ways to help children with learning and behaviour problems, which create substantial costs for society as well as for the individuals concerned. Who can participate? Children aged 7-9 years will be recruited from mainstream schools in counties proximate to Oxfordshire, UK. We will specifically focus on those pupils who fall within the lowest 20th centile on age-standardised tests of reading achievement. What does the study involve? Children aged 7 to 9 years (initially screened via data on literacy attainments held by Local Authorities and schools) will be invited to participate in a short school-based session, involving brief assessments of reading and working memory, an optional pinprick blood sample, and child behaviour ratings from their teachers and parents. What are the possible benefits and risks of participating? Increased intakes of DHA should result in improvements in participants reading and behaviour. We are happy to report that as expected, no serious adverse events were reported from the recent DOLAB study using the same supplement, nor were there any unfavourable side-effects. Given this experience risks for participants are thought to be minimal. Where is the study run from? The study will be undertaken by researchers from the Centre for Evidence Based Intervention at University of Oxford, UK. When is the study starting and how long is it expected to run for? The study started in January 2013 and expected to be finished in August 2015. Who is funding the study? DSM Nutritional Products (USA). Who is the main contact? Mrs Jenny Burton jennifer.burton@spi.ox.ac.uk
Ethics approval	Oxford B NHS Ethics Board, 15th October 2012, ref:12/SC/0465
Study design	Randomised double-blind placebo-controlled trial (fixed dose, parallel groups)
Countries of recruitment	United Kingdom
Disease/condition/study domain	Learning and Behaviour in Children
Participants - inclusion criteria	1. Children (both males and females) aged 7 - 9 years from mainstream state schools who are under performing in literacy skills according to nationally standardised assessments of scholastic achievement at age 7 years (Key Stage 1). To be eligible, children must score below the 20th centile for reading but have no other significant learning difficulty. 2. English as a first language
Participants - exclusion criteria	1. Major learning disabilities or medical disorders 2. Taking medications expected to affect behaviour and learning 3. Taking fish oils already, or eating fish two times or more a week
Anticipated start date	01/01/2013
Anticipated end date	31/07/2015
Status of trial	Ongoing
Patient information material	Not available in web format, please contact Jenny Burton, jennifer.burton@spi.ox.ac.uk to request a patient information sheet
Target number of participants	400 participant (200 per treatment group)
Interventions	The active intervention will consist of 3 x 500 mg capsules per day (to be taken orally with food and drink), each capsule providing 200 mg of DHA as a triglyceride. The liquid fill contains DHASCO®-S oil derived from the microalgae Schizochytrium sp., high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitate, and rosemary extract (flavouring). The gelatin shell contains glycerin, water, and colouring (carmel, carmine, turmeric). The placebo will consist of 3 x 500 mg capsules per day (again, to be taken orally with food and drink) containing soya/corn oil. The dimensions, taste, appearance and colour will be identical to those of the DHA capsules. The shell of the capsule will be the same as the DHA capsule. Duration of interventions: 16 weeks Jenny Burton The DOLAB II Study Centre for Evidence Based Intervention Barnett House 32 Wellington Square Oxford OX1 2ER United Kingdom Tel: +44 (0)1865 270320 E-mail: jennifer.burton@spi.oxac.uk
Primary outcome measure(s)	Children's age-standardised scores for learning (reading performance and working memory) and behaviour (parent ratings of attention deficit hyperactivity disorder [ADHD]-type symptoms) assessed both at baseline and post-intervention. The following validated measures will be used: 1. British Ability Scale (BAS II): Word reading 2. British Ability Scale (BAS II): Recall of Digits 3. Conners Parent Ratings (CPRS-L)
Secondary outcome measure(s)	Behaviour (teacher ratings of attention deficit hyperactivity disorder [ADHD]-type symptoms) assessed both at baseline and post-intervention using Conners Teacher Ratings (CTRS-L)
Sources of funding	DSM Nutritional Products (USA)
Trial website	http://tinyurl.com/Dolab-Studies
Publications
Contact name	Prof Paul Montgomery
Address	University of Oxford Centre for Evidence Based Intervention Barnett House 32 Wellington Square
City/town	Oxford
Zip/Postcode	OX1 2ER
Country	United Kingdom
Email	paul.montgomery@spi.ox.ac.uk
Sponsor	University of Oxford (UK)
Address	Joint Research Office Block 60 Churchill Hospital Headington
City/town	Oxford
Zip/Postcode	OX3 7LE
Country	United Kingdom
Email	heather.house@admin.ox.ac.uk
Sponsor website:	http://www.ox.ac.uk/
Date applied	25/01/2013
Last edited	26/02/2013
Date ISRCTN assigned	26/02/2013


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