Trial record 1 of 1 for:    NCT01066182
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The DHA (Docosahexaenoic Acid) Oxford Learning and Behaviour (DOLAB) Study

This study has been completed.
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT01066182
First received: February 9, 2010
Last updated: October 27, 2011
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Learning
Behaviour
Dietary Supplement: DHA (docosahexaenoic acid)
Dietary Supplement: Sunflower oil capsules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of DHA (Docosahexaenoic Acid)for Learning and Behaviour in Children Aged 7 - 9 Years

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 360
Study Start Date: January 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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).
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).
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).

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.

  Eligibility

Ages Eligible for Study:   7 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066182

Locations
United Kingdom
Department of Social Policy and Social Work
Oxford, Oxfordshire, United Kingdom, OX1 2ER
Sponsors and Collaborators
University of Oxford
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Paul Montgomery, DPhil University of Oxford
Principal Investigator: Alexandra J Richardson, DPhil University of Oxford
  More Information

No publications provided by University of Oxford

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Paul Montgomery, University of Oxford
ClinicalTrials.gov Identifier: NCT01066182     History of Changes
Other Study ID Numbers: 08/H0603/49, R10157/CN001
Study First Received: February 9, 2010
Last Updated: October 27, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
DHA
Learning
Reading
Memory
Children
Omega 3
Education
Learning and behaviour in children

Additional relevant MeSH terms:
6-O-palmitoylascorbic acid
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents

ClinicalTrials.gov processed this record on September 14, 2014