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

University of Oxford

Status and phase: Completed; Phase 2

Conditions: Learning; Behaviour

Treatments: Dietary Supplement: Sunflower oil capsules; Dietary Supplement: DHA (docosahexaenoic acid)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01066182

08/H0603/49

R10157/CN001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 7 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 2 patient groups, including a placebo group

DHA supplement

Experimental group

Description:

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).

Treatment:

Dietary Supplement: DHA (docosahexaenoic acid)

Sunflower oil capsule

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Sunflower oil capsules