The docosahexaneoic acid (DHA) Oxford Learning and Behaviour (DOLAB) Study
| ISRCTN | ISRCTN99771026 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99771026 |
| ClinicalTrials.gov (NCT) | NCT01066182 |
| Protocol serial number | 08/H0603/49 |
| Sponsor | University of Oxford (UK) |
| Funder | Martek Biosciences Corporation (USA) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Docosahexaneoic acid (DHA) (DHASCO®-S) |
| 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: |
| Key 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). |
| Completion date | 24/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 9 Years |
| Sex | All |
| Target sample size at registration | 360 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2009 |
| Date of final enrolment | 24/10/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Centre for Evidence Based Intervention
Oxford
OX1 2ER
United Kingdom
OX1 2ER
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
