Condition category
Mental and Behavioural Disorders
Date applied
25/01/2013
Date assigned
26/02/2013
Last edited
27/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English 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

Trial website

http://tinyurl.com/Dolab-Studies

Contact information

Type

Scientific

Primary contact

Prof Paul Montgomery

ORCID ID

Contact details

University of Oxford
Centre for Evidence Based Intervention
Barnett House
32 Wellington Square
Oxford
OX1 2ER
United Kingdom
-
paul.montgomery@spi.ox.ac.uk

Type

Scientific

Additional contact

Ms Jenny Burton

ORCID ID

Contact details

Centre for Evidence Based Intervention
Barnett House
32 Wellington Square
Oxford
OX1 2ER
United Kingdom
+44 (0)1865 270320
jennifer.burton@spi.oxac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12/SC/0465

Study information

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

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.

Ethics approval

Oxford B NHS Ethics Board, 15/10/2012, ref:12/SC/0465

Study design

Randomised double-blind placebo-controlled trial (fixed dose, parallel groups)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Other

Patient information sheet

Not available in web format, please contact Jenny Burton, jennifer.burton@spi.ox.ac.uk to request a patient information sheet

Condition

Learning and Behaviour in Children

Intervention

Current Intervention as of 01/09/2014:
The active intervention will consist of 3 x 500 mg capsules per day, each capsule providing 200 mg of DHA Omega-3 as a triglyceride. The liquid fill contains DHA-S oil derived from the microalgae, Schizochytrium sp., high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitate, rosemary extract, natural orange flavouring and natural masker. The vegetarian gelatine shell contains carrageenan, non-GMO modified cornstarch, glycerine, sorbitol, water, betacarotene and caramel powder.

The placebo will consist of 3 x 500 mg capsules per day containing corn/soy oil. The dimensions, taste, appearance and colour will be identical to those of the DHA Omega-3 capsules. The shell of the capsule will be the same as the DHA Omega-3 capsule. The liquid fill contains corn/soy oil, natural orange flavouring, natural masker, tocoblend L70 IP, rosemary oil and ascorbyl palmitate.

Previous interventions from 12/03/2014 to 01/09/2014:
The active intervention will consist of 3 x 500 mg capsules per day, each capsule providing 200 mg of DHA Omega-3 as a triglyceride. The liquid fill contains DHA-S oil, derived from the microalgae, Schizochytrium sp., high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitate, and rosemary extract, and orange extract (flavouring). The animal gelatin shell contains glycerin, water, and colouring (sunset yellow [E110]) [details of colouring amended on 10/01/2014].

The placebo will consist of 3 x 500 mg capsules per day containing corn/soy oil. The dimensions, taste, appearance and colour will be identical to those of the DHA Omega-3 capsules. The shell of the capsule will be the same as the DHA Omega-3 capsule. The liquid fill contains corn/soy oil and orange extract (flavouring).

Original 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

Intervention type

Supplement

Phase

Not Applicable

Drug names

Omega 3 supplements [docosahexaenoic acid]

Primary outcome measures

Current primary outcome measures as of 19/06/2013:
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)
4. British Ability Scale (BAS3): Word reading.

Previous primary outcome measures until 19/06/2013:
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 measures

Behaviour (teacher ratings of attention deficit hyperactivity disorder [ADHD]-type symptoms) assessed both at baseline and post-intervention using Conners Teacher Ratings (CTRS-L)

Overall trial start date

01/01/2013

Overall trial end date

31/07/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

400 participant (200 per treatment group)

Participant 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

Recruitment start date

01/01/2013

Recruitment end date

31/07/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Oxford
OX1 2ER
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Joint Research Office
Block 60
Churchill Hospital
Headington
Oxford
OX3 7LE
United Kingdom
-
heather.house@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Industry

Funder name

DSM Nutritional Products (USA)

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