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

NCT ID: NCT01066182

Last Updated: 2011-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-07-31

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.

Conditions

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Learning Behaviour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DHA 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).

Group Type EXPERIMENTAL

DHA (docosahexaenoic acid)

Intervention Type 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 capsule

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).

Group Type PLACEBO_COMPARATOR

Sunflower oil capsules

Intervention Type 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).

Interventions

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DHA (docosahexaenoic acid)

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).

Intervention Type DIETARY_SUPPLEMENT

Sunflower oil capsules

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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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University of Oxford

Principal Investigators

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Paul Montgomery, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Alexandra J Richardson, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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Department of Social Policy and Social Work

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 22970149 (View on PubMed)

Other Identifiers

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R10157/CN001

Identifier Type: -

Identifier Source: secondary_id

08/H0603/49

Identifier Type: -

Identifier Source: org_study_id