The DHA (Docosahexaenoic Acid) Oxford Learning and Behaviour (DOLAB) Study

Learning Clinical Trial

— DOLAB  

Official title:

A Randomised Controlled Trial of DHA (Docosahexaenoic Acid)for Learning and Behaviour in Children Aged 7 - 9 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066182
• Other study ID #: 08/H0603/49
• Secondary ID: R10157/CN001
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2010
• Last updated: October 27, 2011
• Start date: January 2009
• Est. completion date: July 2011

Study information

• 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

Clinical Trial Summary

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.

Description:

The study has two stages, as its primary aim is to find out whether there is a real link between children's fatty acid status and their reading and behaviour. Previous reviews have stated the importance of objective measures, as did our referees.

We will aim to address this by using well validated tests of reading and behaviour, and comparing results from these with children's fatty acid status as assessed from a pinprick blood sample. In Stage 1 we will primarily aim to establish the degree of association between fatty acid status and reading and behaviour. Secondarily, we will look at whether the children who have a higher DHA status have better sleep, and whether in turn they have better reading and/or behaviour, as previous work has suggested this.

In Stage 2 we aim to carry out a randomised trial where children will be given either DHA or a taste− and appearance−matched dummy capsule for 16 weeks. Neither the children, parents nor the researchers will know which children will get which treatment until the study is over.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behaviour
• Learning

Intervention

Dietary Supplement:
• DHA (docosahexaenoic acid)
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).
• Sunflower oil capsules
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).

Locations

Country	Name	City	State
United Kingdom	Department of Social Policy and Social Work	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	DSM Nutritional Products, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

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