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| [ Print-friendly version ] |
| 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 |
| 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 |
| 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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