Trial from ANZCTR


Trial ID ACTRN12605000569606
Trial Status: Registered
Date Submitted: 20/09/2005
Date Registered: 30/09/2005
Prospectively registered

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Public title A Randomised Trial of DHA in pregnancy to prevent postnatal depressive symptoms and enhance neurodevelopment in children: The DOMInO Trial
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A Randomised Trial of DHA in pregnancy to prevent postnatal depressive symptoms and enhance neurodevelopment in children: The DOMInO Trial
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Secondary ID [1] 252352 0
None
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UTN
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Trial acronym DOMInO
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Health condition(s) or problem(s) studied:
Pregnancy 695 0
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Condition category: Condition code:
Reproductive Health and Childbirth Childbirth and postnatal care
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770 770 0 0
Reproductive Health and Childbirth Depression
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Descriptions of intervention(s) / exposure 0.5g DHA rich Tuna Oil Capsules taken from 18-21 weeks until birth.
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Intervention Code:
Prevention 656 0
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Comparator / control treatment 0.5g Blended vegatable oil capsules
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Control group Placebo
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Primary Outcome: Symptoms of postnatal depression 981 0
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Timepoint: At 6 weeks and 6 months post partum 981 0
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Secondary Outcome: Neurodevelopment as assessed by Bayley Scales of Infant Development III (BSID) 1855 0
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Timepoint: 18 months corrected age 1855 0
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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.
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Minimum age Not stated
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Maximum age Not stated
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Gender Females
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Healthy volunteers? No
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Key exclusion criteria Bleeding disorders where DHA rich tuna oil is contraindicated.
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Central Telephone
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Computer generated balanced variable blocks
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Safety/efficacy
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Statistical Methods/Analysis
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Phase Phase 4
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Anticipated date of first participant enrolment 15/10/2005
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 2240
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Recruitment status Closed: follow-up continuing
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Government body 852 0
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Name: NH&MRC 852 0
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Address: National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
852 0
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Country: Australia 852 0
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Primary Sponsor Government body
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Name: NH&MRC
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Address: National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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Country: Australia
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Secondary Sponsor: None 719 0
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Name: not applicable 719 0
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Address: 719 0
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Country: 719 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Children, Youth and Women's Health Services 2117 0
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Address: Adelaide, South Australia 2117 0
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Country: Australia 2117 0
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Approval Date: 2117 0
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Submitted Date: 2117 0
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HREC: 2117 0
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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.
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Helen Loudis
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Address: Child Nutrition Research Centre, 72 King William Road North Adelaide SA 5006
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Tel: +61 8 81618598
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Fax: +61 8 82390267
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Email: helen.loudis@health.sa.gov.au
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Contact person for scientific queries
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Name: Dr Maria Makrides
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Address: Child Nutrition Research Centre, 72 King William Road North Adelaide SA 5006
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Tel: +61 8 81616179
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Fax: +61 8 81618228
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Email: maria.makrides@health.sa.gov.au
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Contact person responsible for updating information
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Name: Helen Loudis
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Address: Child Nutrition Research Centre, 72 King William Road North Adelaide SA 5006
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Country: Australia
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Tel: +61 8 81618598
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Email: helen.loudis@health.sa.gov.au
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Addition Cancer fields
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