Learning Clinical Trial
— DOLABOfficial title:
A Randomised Controlled Trial of DHA (Docosahexaenoic Acid)for Learning and Behaviour in Children Aged 7 - 9 Years
Verified date | February 2010 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
The purpose of this study is to determine whether 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 standardized tests.
Status | Completed |
Enrollment | 360 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 7 Years to 10 Years |
Eligibility |
Inclusion Criteria: 1. Children aged 7 - 9 years from mainstream state schools who are underperforming in literacy skills according to nationally standardized 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. 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 2 times or more a week |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Department of Social Policy and Social Work | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | DSM Nutritional Products, Inc. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Conners Teacher Rating Scale (CTRS-L) | 16 weeks | No | |
Primary | Conners Parent Rating Scale (CPRS-L) | 16 weeks | No | |
Primary | British Ability Scale (BAS) II Word and Digit Span Scales | 16 weeks | No | |
Secondary | Pinprick blood levels of DHA | 16 weeks | No | |
Secondary | Child Sleep Habits Questionnaire (CSHQ) | 16 weeks | No | |
Secondary | Objective sleep as measured by actigraphy | 16 weeks | No |
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