Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001125910
Ethics application status
Approved
Date submitted
26/09/2011
Date registered
27/10/2011
Date last updated
17/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Follow-up of children whose mothers participated in the DOMINO trial: does fish oil supplementation in pregnancy influence child development at 4 years?
Scientific title
Does maternal supplementation with n-3 long-chain PUFA in pregnancy influence cognitive development in childhood?
Secondary ID [1] 273282 0
none
Universal Trial Number (UTN)
Trial acronym
The DOMInO 4 Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive development 270860 0
Condition category
Condition code
Diet and Nutrition 271036 271036 0 0
Other diet and nutrition disorders
Mental Health 279238 279238 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 x 0.5 DHA rich Tuna Oil Capsules taken daily from 18-21 weeks until birth of child in The DOMInO Study.
Intervention code [1] 269451 0
Prevention
Comparator / control treatment
0.5g Blended Vegetable Oil Capsules
Control group
Placebo

Outcomes
Primary outcome [1] 279693 0
Cognitive Developement, as assessed by the Differential Ability Scales, 2nd Edition (DASII).
Timepoint [1] 279693 0
4 years corrected age.
Secondary outcome [1] 294229 0
Language developement, as assessed by the CELF P - Clinical Evaluation of Language Fundamentals during Preschool years.
Timepoint [1] 294229 0
4 years corrected age.

Eligibility
Key inclusion criteria
Children who were included in the secondary outcome (neurodevelopment at 18months as assessed by the BSIDIII) of the original DOMInO Trial .
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central telephone and mail
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated balanced variable blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/06/2010
Actual
18/06/2010
Date of last participant enrolment
Anticipated
25/09/2010
Actual
25/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
709
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269932 0
Government body
Name [1] 269932 0
NH&MRC
Country [1] 269932 0
Australia
Primary sponsor type
Government body
Name
NH&MRC
Address
National Health and Medical Research Council
GPO BOX 1421
CANBERRA ACT 2601
Country
Australia
Secondary sponsor category [1] 268933 0
None
Name [1] 268933 0
Address [1] 268933 0
Country [1] 268933 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271899 0
Women's and Children's Health Network
Ethics committee address [1] 271899 0
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Ethics committee country [1] 271899 0
Australia
Date submitted for ethics approval [1] 271899 0
Approval date [1] 271899 0
25/03/2010
Ethics approval number [1] 271899 0
12/12/2242

Summary
Brief summary
The primary aim is to determine whether supplementing pregnant women with DHA-rich capsules from 18-21 weeks of prengnacy until delivery will enhance the general cognitive ability of children at 4 years of age.

Hypothesis: Children whose mothers took DHA-rich fish oil capsules during the second half of pregnancy will have enhanced cognitive development at 4 years of age compared with children whose mothers consumed a placebo.
This will be investigated using psychometric assessments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33200 0
Prof Maria Makrides
Address 33200 0
Women's and Children's Health Research Institute
Level 7, CRB Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006
Country 33200 0
Australia
Phone 33200 0
+61 (0)8 8161 6067
Fax 33200 0
+61 (0)8 8239 0267
Email 33200 0
maria.makrides@health.sa.gov.au
Contact person for public queries
Name 16447 0
Helen Loudis
Address 16447 0
Child Nutrition Research Centre
Flinders Medical Centre
Flinders Drive
BEDFORD PARK SA 5042
Country 16447 0
Australia
Phone 16447 0
+61 8 82045515
Fax 16447 0
+61 8 82046296
Email 16447 0
helen.loudis@health.sa.gov.au
Contact person for scientific queries
Name 7375 0
Maria Makrides
Address 7375 0
Women's and Children's Health Research Institute
Level 7, CRB Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006
Country 7375 0
Australia
Phone 7375 0
+61 8 81616719
Fax 7375 0
+61 8 82390267
Email 7375 0
maria.makrides@health.sa.gov.au

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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