DHA To Optimise Mother Infant Outcome: The DOMInO Trial
South Australian Health and Medical Research Institute (SAHMRI)Dataset description
This dataset included 2399 women who had singleton pregnancy of <21 weeks' gestation with no fetal abnormality. 97.3% of women in the DHA group (intervention) took 0.5g DHA rich Tuna Oil Capsules taken from 18-21 weeks until birth and 96.1% took 0.5g blended vegetable oil capsules (placebo). Symptoms of postnatal depression were assessed at 6 weeks and 6 months post-partum using the self-administered Edinburgh Postnatal Depression Scale (EPDS). In addition, 694 children's cognitive and language development was assessed by Bayley Scales of Infant Development, Third Edition, at 18 months corrected age. The primary outcome of this study was to determine if increasing the amount of DHA in the diet reduces feelings of post-natal depression in women.Date Information
Identifiers
Source Study
Purpose:
Phase:
Trial acronym
DOMInO
Trial ID
ACTRN12605000569606
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 depressionTimepoint: At 6 weeks and 6 months post partum
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