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Completed

NCT Number: NCT01066182

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

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.

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Key information

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Social Policy and Social Work

Oxford, Oxfordshire, OX1 2ER, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DHA (docosahexaenoic acid)

Dietary Supplement

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).

Sunflower oil capsules

Dietary Supplement

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).

Primary outcomes

  1. Conners Teacher Rating Scale (CTRS-L)

    Time frame: 16 weeks

  2. Conners Parent Rating Scale (CPRS-L)

    Time frame: 16 weeks

  3. British Ability Scale (BAS) II Word and Digit Span Scales

    Time frame: 16 weeks

Secondary outcomes

  1. Pinprick blood levels of DHA

    Time frame: 16 weeks

  2. Child Sleep Habits Questionnaire (CSHQ)

    Time frame: 16 weeks

  3. Objective sleep as measured by actigraphy

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • dsm-firmenich Switzerland AG

Registry information

Official study title

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

Acronym: DOLAB

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 10, 2010
Registry last updated
Oct 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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