Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/02/2009
Date assigned
07/04/2009
Last edited
17/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Montgomery

ORCID ID

Contact details

Centre for Evidence Based Intervention
Barnett House
32 Wellington Square
Oxford
OX1 2ER
United Kingdom
+44 (0)1865 280325
paul.montgomery@socres.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01066182

Protocol/serial number

08/H0603/49

Study information

Scientific title

The docosahexaneoic acid (DHA) Oxford Learning and Behaviour (DOLAB) Study: a randomised double-blind placebo-controlled trial

Acronym

DOLAB

Study hypothesis

We hypothesise that docosahexaneoic acid (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 standardised tests.
Please note as of 13/12/2011 the target number of participants were modified
Previously target number of participants: 360 (Recruitment complete as of 24/10/2011)

Ethics approval

NHS Milton Keynes Research Ethics Committee approved on the 8th December 2008 (ref: 08/H0603/49)

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet

Condition

Learning and behaviour in children

Intervention

The active intervention will consist of 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).

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).

Duration of interventions: 16 weeks

Please use the following contact details to request a patient information sheet:
Jenny Burton
The DOLAB Study
Centre for Evidence Based Intervention
Barnett House
32 Wellington Square
Oxford
OX1 2ER
United Kingdom
Tel: +44 (0)1865 270320
E-mail: jennifer.burton@socres.oxac.uk

Intervention type

Drug

Phase

Not Applicable

Drug names

Docosahexaneoic acid (DHA) (DHASCO®-S)

Primary outcome measures

Children's age-standardised scores for behaviour (teacher ratings of attention deficit hyperactivity disorder [ADHD]-type symptoms) and learning (reading performance and working memory), assessed post-intervention. The following validated measures will be used:
1. Conners Teacher and Parent Ratings (CTRS-L and CPRS-L)
2. British Ability Scale (BAS II): Word reading
3. British Ability Scale (BAS II): Recall of Digits

Secondary outcome measures

Correlations between changes in omega-3 (DHA) status and the primary outcomes plus any post-intervention changes in sleep (Combined Sleep Disturbance Index, and in 10% subset monitored objectively with actigraphy, sleep latency and duration).

Overall trial start date

01/03/2009

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children (both males and females) aged 7 - 9 years from mainstream state schools who are underperforming in literacy skills according to nationally standardised 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

360 (Recruitment complete as of 01/07/2011)

Participant 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 two times or more a week

Recruitment start date

01/03/2009

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Evidence Based Intervention
Oxford
OX1 2ER
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 222757
heather.house@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Industry

Funder name

Martek Biosciences Corporation (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22970149

Publication citations

  1. Results

    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.

Additional files

Editorial Notes