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

This study has been completed.
Sponsor:
Collaborator:
Martek Biosciences Corporation
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT01066182
First received: February 9, 2010
Last updated: October 27, 2011
Last verified: February 2010

February 9, 2010
October 27, 2011
January 2009
July 2011   (final data collection date for primary outcome measure)
  • Conners Teacher Rating Scale (CTRS-L) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Conners Parent Rating Scale (CPRS-L) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • British Ability Scale (BAS) II Word and Digit Span Scales [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01066182 on ClinicalTrials.gov Archive Site
  • Pinprick blood levels of DHA [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Child Sleep Habits Questionnaire (CSHQ) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Objective sleep as measured by actigraphy [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The DHA (Docosahexaenoic Acid) Oxford Learning and Behaviour (DOLAB) Study
A Randomised Controlled Trial of DHA (Docosahexaenoic Acid)for Learning and Behaviour in Children Aged 7 - 9 Years

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Learning
  • Behaviour
  • 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).
  • Dietary Supplement: 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).
  • Experimental: DHA supplement
    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).
    Intervention: Dietary Supplement: DHA (docosahexaenoic acid)
  • Placebo Comparator: Sunflower oil capsule
    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).
    Intervention: Dietary Supplement: Sunflower oil capsules
Richardson AJ, Burton JR, Sewell RP, Spreckelsen TF, Montgomery P. Docosahexaenoic acid for reading, cognition and behavior in children aged 7-9 years: a randomized, controlled trial (the DOLAB Study). PLoS One. 2012;7(9):e43909. doi: 10.1371/journal.pone.0043909. Epub 2012 Sep 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
7 Years to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01066182
08/H0603/49, R10157/CN001
Yes
Dr. Paul Montgomery, University of Oxford
University of Oxford
Martek Biosciences Corporation
Principal Investigator: Paul Montgomery, DPhil University of Oxford
Principal Investigator: Alexandra J Richardson, DPhil University of Oxford
University of Oxford
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP