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

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ClinicalTrials.gov Identifier: NCT01066182
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : October 28, 2011
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by:
University of Oxford

Tracking Information
First Submitted Date  ICMJE February 9, 2010
First Posted Date  ICMJE February 10, 2010
Last Update Posted Date October 28, 2011
Study Start Date  ICMJE January 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2010)
  • Conners Teacher Rating Scale (CTRS-L) [ Time Frame: 16 weeks ]
  • Conners Parent Rating Scale (CPRS-L) [ Time Frame: 16 weeks ]
  • British Ability Scale (BAS) II Word and Digit Span Scales [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01066182 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2010)
  • Pinprick blood levels of DHA [ Time Frame: 16 weeks ]
  • Child Sleep Habits Questionnaire (CSHQ) [ Time Frame: 16 weeks ]
  • Objective sleep as measured by actigraphy [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The DHA (Docosahexaenoic Acid) Oxford Learning and Behaviour (DOLAB) Study
Official Title  ICMJE A Randomised Controlled Trial of DHA (Docosahexaenoic Acid)for Learning and Behaviour in Children Aged 7 - 9 Years
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Learning
  • Behaviour
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 9, 2010)
360
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01066182
Other Study ID Numbers  ICMJE 08/H0603/49
R10157/CN001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Paul Montgomery, University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE DSM Nutritional Products, Inc.
Investigators  ICMJE
Principal Investigator: Paul Montgomery, DPhil University of Oxford
Principal Investigator: Alexandra J Richardson, DPhil University of Oxford
PRS Account University of Oxford
Verification Date February 2010

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