Trial registered on ANZCTR


Trial ID
ACTRN12605000569606
Ethics application status
Approved
Date submitted
20/09/2005
Date registered
30/09/2005
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
Not stated
Maximum age
Not stated
Gender
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

Recruitment
Anticipated date of first participant enrolment
15/10/2005
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
2240
Actual sample size
Recruitment status
Active, not recruiting
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 852 0
Government body
Name [1] 852 0
NH&MRC
Address [1] 852 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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
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
Public notes

Contacts
Principal investigator
Name 35607 0
Address 35607 0
Country 35607 0
Phone 35607 0
Fax 35607 0
Email 35607 0
Contact person for public queries
Name 9845 0
Helen Loudis
Address 9845 0
Child Nutrition Research Centre, 72 King William Road North Adelaide SA 5006
Country 9845 0
Australia
Phone 9845 0
+61 8 81618598
Fax 9845 0
+61 8 82390267
Email 9845 0
helen.loudis@health.sa.gov.au
Contact person for scientific queries
Name 773 0
Dr Maria Makrides
Address 773 0
Child Nutrition Research Centre, 72 King William Road North Adelaide SA 5006
Country 773 0
Australia
Phone 773 0
+61 8 81616179
Fax 773 0
+61 8 81618228
Email 773 0
maria.makrides@health.sa.gov.au