Learning Clinical Trial
Official title:
A Randomised Controlled Trial of DHA (Docosahexaenoic Acid)for Learning and Behaviour in Children Aged 7 - 9 Years
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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