Trial Review

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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 information initially 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
Scientific title
A Randomised Trial of DHA in pregnancy to prevent postnatal depressive symptoms and enhance neurodevelopment in children: The DOMInO Trial
Secondary ID [1] 252352 0
None
Universal Trial Number (UTN)
Trial acronym
DOMInO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 695 0
Condition category
Condition code
Reproductive Health and Childbirth 770 770 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 771 771 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.5g DHA rich Tuna Oil Capsules taken from 18-21 weeks until birth.
Intervention code [1] 656 0
Prevention
Comparator / control treatment
0.5g Blended vegatable oil capsules
Control group
Placebo

Outcomes
Primary outcome [1] 981 0
Symptoms of postnatal depression
Timepoint [1] 981 0
At 6 weeks and 6 months post partum
Secondary outcome [1] 1855 0
Neurodevelopment as assessed by Bayley Scales of Infant Development III (BSID)
Timepoint [1] 1855 0
18 months corrected age

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.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Bleeding disorders where DHA rich tuna oil is contraindicated.

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
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
15/10/2005
Actual
31/10/2005
Date of last participant enrolment
Anticipated
Actual
11/01/2008
Date of last data collection
Anticipated
Actual
16/12/2009
Sample size
Target
2240
Accrual to date
Final
2399
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 852 0
Government body
Name [1] 852 0
NH&MRC
Country [1] 852 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] 719 0
None
Name [1] 719 0
not applicable
Address [1] 719 0
Country [1] 719 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2117 0
Children, Youth and Women's Health Services
Ethics committee address [1] 2117 0
Adelaide, South Australia
Ethics committee country [1] 2117 0
Australia
Date submitted for ethics approval [1] 2117 0
Approval date [1] 2117 0
06/09/2005
Ethics approval number [1] 2117 0

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.
Trial website
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.
Public notes

Contacts
Principal investigator
Name 35607 0
Prof Maria Makrides
Address 35607 0
SAHMRI, North Terrace, Adelaide SA 5000 Australia
Country 35607 0
Australia
Phone 35607 0
+618 8128 4416
Fax 35607 0
+61 8 8303 7135
Email 35607 0
maria.makrides@sahmri.com
Contact person for public queries
Name 9845 0
Prof Maria Makrides
Address 9845 0
SAHMRI, North Terrace, Adelaide SA 5000 Australia
Country 9845 0
Australia
Phone 9845 0
+618 8128 4416
Fax 9845 0
+61 8 8303 7135
Email 9845 0
maria.makrides@sahmri.com
Contact person for scientific queries
Name 773 0
Prof Maria Makrides
Address 773 0
SAHMRI, North Terrace, Adelaide SA 5000 Australia
Country 773 0
Australia
Phone 773 0
+618 8128 4416
Fax 773 0
+61 8 8303 7135
Email 773 0
maria.makrides@sahmri.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
When will data be available (start and end dates)?
Available after publication with no end date determined
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
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
How or where can data be obtained?
All data requests should be made to maria.makrides@sahmri.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19409Study protocol  maria.makrides@sahmri.com
19410Statistical analysis plan  maria.makrides@sahmri.com
19411Other  maria.makrides@sahmri.com Case report form


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Makrides M, Gibson RA, McPhee AJ, Yelland L, Quinl... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of prenatal DHA supplementation on the infant epigenome: results from a randomized controlled trial.2016https://dx.doi.org/10.1186/s13148-016-0281-7
EmbasePrenatal fish oil supplementation and allergy: 6-Year follow-up of a randomized controlled trial.2016https://dx.doi.org/10.1542/peds.2015-4443
EmbaseDoes n-3 LCPUFA supplementation during pregnancy increase the IQ of children at school age? Follow-up of a randomised controlled trial.2016https://dx.doi.org/10.1136/bmjopen-2016-011465
EmbasePredicting 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.2016https://dx.doi.org/10.1016/j.plefa.2016.08.007
EmbaseHigher cord blood 25-hydroxyvitamin D concentrations reduce the risk of early childhood eczema: In children with a family history of allergic disease.2015https://dx.doi.org/10.1186/s40413-015-0077-9
EmbaseModifying the infant's diet to prevent food allergy.2017https://dx.doi.org/10.1136/archdischild-2015-309770
EmbaseDNA methylation in blood from neonatal screening cards and the association with BMI and insulin sensitivity in early childhood.2018https://dx.doi.org/10.1038/ijo.2017.228
EmbasePrenatal 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.2018https://dx.doi.org/10.1186/s40413-018-0190-7
Dimensions AIMaternal supplementation with docosahexaenoic acid during pregnancy does not affect early visual development in the infant: a randomized controlled trial2011https://doi.org/10.3945/ajcn.110.009647
Dimensions AIEffect of n-3 long chain polyunsaturated fatty acid supplementation in pregnancy on infants’ allergies in first year of life: randomised controlled trial2012https://doi.org/10.1136/bmj.e184
Dimensions AIRandomized controlled trial of fish oil supplementation in pregnancy on childhood allergies2013https://doi.org/10.1111/all.12233
N.B. These documents automatically identified may not have been verified by the study sponsor.