Data

DHA To Optimise Mother Infant Outcome: The DOMInO Trial

South Australian Health and Medical Research Institute (SAHMRI)

Dataset description

A Randomised Trial of DHA in pregnancy to prevent postnatal depressive symptoms and enhance neurodevelopment in children: The DOMInO Trial
Click to explore relationships graph

Source Study

Purpose

Prevention

Phase

Phase 4

Funding

Government body,NH&MRC

Scientific enquiries

Prof Maria Makrides

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 ....
Read more

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.

Key Exclusion Criteria

Bleeding disorders where DHA rich tuna oil is contraindicated.

Can healthy volunteers participate?

No

 

Population

Sample Size    2399

Min. age    0 No limit

Max. age    0 No limit

Sex    Females

Condition category    Pregnancy

Condition code    Reproductive Health and Childbirth

Intervention

Intervention code Prevention

0.5g DHA rich Tuna Oil Capsules taken from 18-21 weeks until birth.

Comparison

Control group Placebo

0.5g Blended vegatable oil capsules

Outcomes

Outcome: Symptoms of postnatal depression
Timepoint: At 6 weeks and 6 months post partum

Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

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?

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

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au