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The docosahexaneoic acid (DHA) Oxford Learning and Behaviour (DOLAB) Study
ISRCTN ISRCTN99771026
DOI 10.1186/ISRCTN99771026
ClinicalTrials.gov identifier NCT01066182
EudraCT number
Public title The docosahexaneoic acid (DHA) Oxford Learning and Behaviour (DOLAB) Study
Scientific title The docosahexaneoic acid (DHA) Oxford Learning and Behaviour (DOLAB) Study: a randomised double-blind placebo-controlled trial
Acronym DOLAB
Serial number at source 08/H0603/49
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)
Lay summary Not provided at time of registration
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
Countries of recruitment United Kingdom
Disease/condition/study domain Learning and behaviour in children
Participants - 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
Participants - 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
Anticipated start date 01/03/2009
Anticipated end date 31/12/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet
Target number of participants 360 (Recruitment complete as of 01/07/2011)
Interventions 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
Primary outcome measure(s) 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 measure(s) 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).
Sources of funding Martek Biosciences Corporation (USA)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22970149
Contact name Dr  Paul  Montgomery
  Address Centre for Evidence Based Intervention
Barnett House
32 Wellington Square
  City/town Oxford
  Zip/Postcode OX1 2ER
  Country United Kingdom
  Tel +44 (0)1865 280325
  Fax +44 (0)1865 270324
  Email paul.montgomery@socres.ox.ac.uk
Sponsor University of Oxford (UK)
  Address Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
  City/town Oxford
  Zip/Postcode OX3 9DU
  Country United Kingdom
  Tel +44 (0)1865 222757
  Fax +44 (0)1865 743002
  Email heather.house@admin.ox.ac.uk
  Sponsor website: http://www.ox.ac.uk/
Date applied 20/02/2009
Last edited 17/09/2012
Date ISRCTN assigned 07/04/2009
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