The docosahexaneoic acid (DHA) Oxford Learning and Behaviour (DOLAB) Study
| ISRCTN | ISRCTN99771026 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99771026 |
| ClinicalTrials.gov number | NCT01066182 |
| Secondary identifying numbers | 08/H0603/49 |
- Submission date
- 20/02/2009
- Registration date
- 07/04/2009
- Last edited
- 12/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Paul Montgomery
Scientific
Scientific
Centre for Evidence Based Intervention
Barnett House
32 Wellington Square
Oxford
OX1 2ER
United Kingdom
| Phone | +44 (0)1865 280325 |
|---|---|
| paul.montgomery@socres.ox.ac.uk |
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet |
| Scientific title | The docosahexaneoic acid (DHA) Oxford Learning and Behaviour (DOLAB) Study: a randomised double-blind placebo-controlled trial |
| Study 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 |
| Ethics approval(s) | NHS Milton Keynes Research Ethics Committee, 08/12/2008, ref: 08/H0603/49 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Docosahexaneoic acid (DHA) (DHASCO®-S) |
| Primary outcome measure | 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 study start date | 01/03/2009 |
| Overall study end date | 24/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 9 Years |
| Sex | Both |
| Target number of participants | 360 |
| 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 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 | 24/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Evidence Based Intervention
Oxford
OX1 2ER
United Kingdom
OX1 2ER
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Oxford
OX3 9DU
England
United Kingdom
| Phone | +44 (0)1865 222757 |
|---|---|
| heather.house@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Industry
Martek Biosciences Corporation (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2012 | Yes | No |
