The DHA (Docosahexaenoic Acid) Oxford Learning and Behaviour (DOLAB) Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised Controlled Trial of DHA (Docosahexaenoic Acid)for Learning and Behaviour in Children Aged 7 - 9 Years

Conditions
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Learning, Behaviour

Intervention / Treatment
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* Dietary Supplement: DHA (docosahexaenoic acid)
* Dietary Supplement: Sunflower oil capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. English as a first language. Exclusion Criteria: Major learning disabilities or medical disorders Taking medications expected to affect behaviour and learning Taking fish oils already, or eating fish 2 times or more a week

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHA supplement<br>3 x 500 mg capsules per day orally, 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). | Dietary Supplement: DHA (docosahexaenoic acid)<br>* 3 x 500 mg capsules per day orally, 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).<br>|
| Placebo Comparator: Sunflower oil capsule<br>The placebo will consist of 3 x 500 mg capsules per day orally containing high-oleic sunflower 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. The liquid fill contains high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitat and rosemary extract (flavouring). | Dietary Supplement: Sunflower oil capsules<br>* The placebo will consist of 3 x 500 mg capsules per day orally containing high-oleic sunflower 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. The liquid fill contains high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitat and rosemary extract (flavouring).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conners Teacher Rating Scale (CTRS-L) |  | 16 weeks | 
| Conners Parent Rating Scale (CPRS-L) |  | 16 weeks | 
| British Ability Scale (BAS) II Word and Digit Span Scales |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pinprick blood levels of DHA |  | 16 weeks | 
| Child Sleep Habits Questionnaire (CSHQ) |  | 16 weeks | 
| Objective sleep as measured by actigraphy |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DHA, Learning, Reading, Memory, Children, Omega 3, Education, Learning and behaviour in children