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Trial registered on ANZCTR
Registration number
ACTRN12605000569606
Ethics application status
Approved
Date submitted
20/09/2005
Date registered
30/09/2005
Date last updated
8/06/2023
Date data sharing statement initially provided
8/06/2023
Date results provided
8/06/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
A Randomised Trial of DHA in pregnancy to prevent postnatal depressive symptoms and enhance neurodevelopment in children: The DOMInO Trial
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Scientific title
A Randomised Trial of DHA in pregnancy to prevent postnatal depressive symptoms and enhance neurodevelopment in children: The DOMInO Trial
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Secondary ID [1]
252352
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None
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Universal Trial Number (UTN)
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Trial acronym
DOMInO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pregnancy
695
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Condition category
Condition code
Reproductive Health and Childbirth
770
770
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0
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Childbirth and postnatal care
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Reproductive Health and Childbirth
771
771
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
0.5g DHA rich Tuna Oil Capsules taken from 18-21 weeks until birth.
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Intervention code [1]
656
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Prevention
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Comparator / control treatment
0.5g Blended vegatable oil capsules
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Symptoms of postnatal depression
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Assessment method [1]
981
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Timepoint [1]
981
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At 6 weeks and 6 months post partum
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Secondary outcome [1]
1855
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Neurodevelopment as assessed by Bayley Scales of Infant Development III (BSID)
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Assessment method [1]
1855
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Timepoint [1]
1855
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18 months corrected age
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Eligibility
Key inclusion criteria
Singleton pregnancy of 18-21 weeks gestation; no known fetal abnormality; women with no documented history of alcohol or drug abuse; no participation in other clinical trials with fatty acid intervention.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Bleeding disorders where DHA rich tuna oil is contraindicated.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Telephone
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated balanced variable blocks
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
15/10/2005
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Actual
31/10/2005
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Date of last participant enrolment
Anticipated
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Actual
11/01/2008
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Date of last data collection
Anticipated
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Actual
16/12/2009
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Sample size
Target
2240
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Accrual to date
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Final
2399
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Funding & Sponsors
Funding source category [1]
852
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Government body
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Name [1]
852
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NH&MRC
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Address [1]
852
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National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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Country [1]
852
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Australia
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Primary sponsor type
Government body
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Name
NH&MRC
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Address
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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Country
Australia
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Secondary sponsor category [1]
719
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None
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Name [1]
719
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not applicable
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Address [1]
719
0
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Country [1]
719
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
2117
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Children, Youth and Women's Health Services
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Ethics committee address [1]
2117
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Adelaide, South Australia
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Ethics committee country [1]
2117
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Australia
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Date submitted for ethics approval [1]
2117
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Approval date [1]
2117
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06/09/2005
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Ethics approval number [1]
2117
0
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Summary
Brief summary
DHA is an omega-3 fat found in fish and fish oils and is thought to play a role in the way the brain works and develops. It has been suggested that supplementing the diet with DHA may reduce feelings of depression, while studies with young infants suggest that enriching the diet with DHA may also help improve visual development. While in the womb, the baby is supplied with DHA from the mothers circulation. The level of DHA in the mothers circulation is largely determined by the amount of DHA in the mothers diet. Australian women generally have low levels of DHA. This study will help determine whether increasing the amount of DHA in the diet improves outcome for women and their babies.
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Trial website
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Trial related presentations / publications
Makrides M, Gibson RA, McPhee AJ, Yelland L, Quinlivan J, Ryan P; DOMInO Investigative Team. Effect of DHA supplementation during pregnancy on maternal depression and neurodevelopment of young children: a randomized controlled trial. JAMA. 2010 Oct 20;304(15):1675-83. doi: 10.1001/jama.2010.1507.
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Public notes
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Contacts
Principal investigator
Name
35607
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Prof Maria Makrides
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Address
35607
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SAHMRI, North Terrace, Adelaide SA 5000 Australia
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Country
35607
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Australia
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Phone
35607
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+618 8128 4416
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Fax
35607
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+61 8 8303 7135
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Email
35607
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maria.makrides@sahmri.com
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Contact person for public queries
Name
9845
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Maria Makrides
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Address
9845
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SAHMRI, North Terrace, Adelaide SA 5000 Australia
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Country
9845
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Australia
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Phone
9845
0
+618 8128 4416
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Fax
9845
0
+61 8 8303 7135
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Email
9845
0
maria.makrides@sahmri.com
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Contact person for scientific queries
Name
773
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Maria Makrides
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Address
773
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SAHMRI, North Terrace, Adelaide SA 5000 Australia
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Country
773
0
Australia
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Phone
773
0
+618 8128 4416
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Fax
773
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+61 8 8303 7135
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Email
773
0
maria.makrides@sahmri.com
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified, individual participant data (IPD) that underlie the results reported in the primary paper (text, tables, figures and appendices) will be available. Dataset(s) will be limited to those participants and variables that are necessary for completion of the approved research proposal.
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When will data be available (start and end dates)?
Available after publication with no end date determined
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Available to whom?
Data will be available to researchers who provide a methodologically sound research proposal following review and approval by the trial steering committee and completion of a signed data access agreement
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Available for what types of analyses?
Data may be shared with researchers who provide a methodologically sound research proposal following review and approval by the trial steering committee and completion of a signed data access agreement
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How or where can data be obtained?
All data requests should be made to maria.makrides@sahmri.com
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
19409
Study protocol
maria.makrides@sahmri.com
19410
Statistical analysis plan
maria.makrides@sahmri.com
19411
Other
maria.makrides@sahmri.com
Case report form
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
Maternal supplementation with docosahexaenoic acid during pregnancy does not affect early visual development in the infant: a randomized controlled trial
2011
https://doi.org/10.3945/ajcn.110.009647
Dimensions AI
Effect of n-3 long chain polyunsaturated fatty acid supplementation in pregnancy on infants’ allergies in first year of life: randomised controlled trial
2012
https://doi.org/10.1136/bmj.e184
Dimensions AI
Randomized controlled trial of fish oil supplementation in pregnancy on childhood allergies
2013
https://doi.org/10.1111/all.12233
Embase
Higher cord blood 25-hydroxyvitamin D concentrations reduce the risk of early childhood eczema: In children with a family history of allergic disease.
2015
https://dx.doi.org/10.1186/s40413-015-0077-9
Embase
Does n-3 LCPUFA supplementation during pregnancy increase the IQ of children at school age? Follow-up of a randomised controlled trial.
2016
https://dx.doi.org/10.1136/bmjopen-2016-011465
Embase
Effect of prenatal DHA supplementation on the infant epigenome: results from a randomized controlled trial.
2016
https://dx.doi.org/10.1186/s13148-016-0281-7
Embase
Predicting the effect of maternal docosahexaenoic acid (DHA) supplementation to reduce early preterm birth in Australia and the United States using results of within country randomized controlled trials.
2016
https://dx.doi.org/10.1016/j.plefa.2016.08.007
Embase
Prenatal fish oil supplementation and allergy: 6-Year follow-up of a randomized controlled trial.
2016
https://dx.doi.org/10.1542/peds.2015-4443
Embase
Modifying the infant's diet to prevent food allergy.
2017
https://dx.doi.org/10.1136/archdischild-2015-309770
Embase
DNA methylation in blood from neonatal screening cards and the association with BMI and insulin sensitivity in early childhood.
2018
https://dx.doi.org/10.1038/ijo.2017.228
Embase
Prenatal omega-3 LCPUFA and symptoms of allergic disease and sensitization throughout early childhood - A longitudinal analysis of long-term follow-up of a randomized controlled trial.
2018
https://dx.doi.org/10.1186/s40413-018-0190-7
N.B. These documents automatically identified may not have been verified by the study sponsor.
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