Clinical trial NCT01066182: The DHA (Docosahexaenoic Acid) Oxford Learning and Behaviour (DOLAB) Study
Official title: A Randomised Controlled Trial of DHA (Docosahexaenoic Acid)for Learning and Behaviour in Children Aged 7 - 9 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Learning
Behaviour
Keywords: DHA
Learning
Reading
Memory
Children
Omega 3
Education
Learning and behaviour in children
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2010-02-10
Enrollment: 360
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether 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 underperforming according to nationally standardized tests.

Detailed description: The study has two stages, as its primary aim is to find out whether there is a real link between children's fatty acid status and their reading and behaviour. Previous reviews have stated the importance of objective measures, as did our referees.

We will aim to address this by using well validated tests of reading and behaviour, and comparing results from these with children's fatty acid status as assessed from a pinprick blood sample. In Stage 1 we will primarily aim to establish the degree of association between fatty acid status and reading and behaviour. Secondarily, we will look at whether the children who have a higher DHA status have better sleep, and whether in turn they have better reading and/or behaviour, as previous work has suggested this.

In Stage 2 we aim to carry out a randomised trial where children will be given either DHA or a taste- and appearance-matched dummy capsule for 16 weeks. Neither the children, parents nor the researchers will know which children will get which treatment until the study is over.

Eligibility criteria: Inclusion Criteria:

1. Children aged 7 - 9 years from mainstream state schools who are underperforming in literacy skills according to nationally standardized assessments of scholastic achievement at age 7 years (Key Stage 1 ). To be eligible, children must score below the 33rd centile for reading/writing, but within the normal range in at least one other domain.
2. English as a first language.

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 2 times or more a week

Primary outcomes:
measure: Conners Teacher Rating Scale (CTRS-L)
timeFrame: 16 weeks
measure: Conners Parent Rating Scale (CPRS-L)
timeFrame: 16 weeks
measure: British Ability Scale (BAS) II Word and Digit Span Scales
timeFrame: 16 weeks
Secondary outcomes:
measure: Pinprick blood levels of DHA
timeFrame: 16 weeks
measure: Child Sleep Habits Questionnaire (CSHQ)
timeFrame: 16 weeks
measure: Objective sleep as measured by actigraphy
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Department of Social Policy and Social Work
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Paul Montgomery, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: Alexandra J Richardson, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Richardson AJ, Burton JR, Sewell RP, Spreckelsen TF, Montgomery P. Docosahexaenoic acid for reading, cognition and behavior in children aged 7-9 years: a randomized, controlled trial (the DOLAB Study). PLoS One. 2012;7(9):e43909. doi: 10.1371/journal.pone.0043909. Epub 2012 Sep 6.