ANZCTR - Registration

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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

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]

None

Universal Trial Number (UTN)

Trial acronym

DOMInO

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pregnancy

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Reproductive Health and Childbirth

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]

Prevention

Comparator / control treatment

0.5g Blended vegatable oil capsules

Control group

Placebo

Outcomes

Primary outcome [1]

Symptoms of postnatal depression

Timepoint [1]

At 6 weeks and 6 months post partum

Secondary outcome [1]

Neurodevelopment as assessed by Bayley Scales of Infant Development III (BSID)

Timepoint [1]

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?

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]

Government body

Name [1]

NH&MRC

Address [1]

National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601

Country [1]

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]

None

Name [1]

not applicable

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children, Youth and Women's Health Services

Ethics committee address [1]

Adelaide, South Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/09/2005

Ethics approval number [1]

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

Prof Maria Makrides

Address

SAHMRI, North Terrace, Adelaide SA 5000 Australia

Country

Australia

Phone

+618 8128 4416

Fax

+61 8 8303 7135

[email protected]

Contact person for public queries

Name

Maria Makrides

Address

SAHMRI, North Terrace, Adelaide SA 5000 Australia

Country

Australia

Phone

+618 8128 4416

Fax

+61 8 8303 7135

[email protected]

Contact person for scientific queries

Name

Maria Makrides

Address

SAHMRI, North Terrace, Adelaide SA 5000 Australia

Country

Australia

Phone

+618 8128 4416

Fax

+61 8 8303 7135

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• 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

Conditions for requesting access:
• -

What individual participant data might 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.

What types of analyses could be done with individual participant data?

• 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

When can requests for individual participant data be made (start and end dates)?

From:
Available after publication with no end date determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• All data requests should be made to [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details
19409	Study protocol	[email protected]
19410	Statistical analysis plan	[email protected]
19411	Other	[email protected]	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.

Trial Review

Documents added manually

Documents added automatically