NCT01066182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 28, 2011

Status Verified

February 1, 2010

Enrollment Period

2.5 years

First QC Date

February 9, 2010

Last Update Submit

October 27, 2011

Conditions

LearningBehaviour

Keywords

DHALearningReadingMemoryChildrenOmega 3EducationLearning and behaviour in children

Outcome Measures

Primary Outcomes (3)

  • Conners Teacher Rating Scale (CTRS-L)

    16 weeks

  • Conners Parent Rating Scale (CPRS-L)

    16 weeks

  • British Ability Scale (BAS) II Word and Digit Span Scales

    16 weeks

Secondary Outcomes (3)

  • Pinprick blood levels of DHA

    16 weeks

  • Child Sleep Habits Questionnaire (CSHQ)

    16 weeks

  • Objective sleep as measured by actigraphy

    16 weeks

Study Arms (2)

DHA supplement

EXPERIMENTAL

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)

Sunflower oil capsule

PLACEBO COMPARATOR

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

Interventions

DHA (docosahexaenoic acid)DIETARY_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).

DHA supplement
Sunflower oil capsulesDIETARY_SUPPLEMENT

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).

Sunflower oil capsule

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • English as a first language.

You may not qualify if:

  • Major learning disabilities or medical disorders
  • Taking medications expected to affect behaviour and learning
  • Taking fish oils already, or eating fish 2 times or more a week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Social Policy and Social Work

Oxford, Oxfordshire, OX1 2ER, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 22970149DERIVED

MeSH Terms

Conditions

Behavior

Interventions

Docosahexaenoic AcidsSunflower Oil

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsPlant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Paul Montgomery, DPhil

    University of Oxford

    PRINCIPAL INVESTIGATOR

  • Alexandra J Richardson, DPhil

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 10, 2010

Study Start

January 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 28, 2011

Record last verified: 2010-02

Locations

GB(1)