Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001123639
Ethics application status
Approved
Date submitted
14/09/2023
Date registered
31/10/2023
Date last updated
31/10/2023
Date data sharing statement initially provided
31/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the optimal dose of omega-3 fatty acids in pregnancy for women with moderate status (OPAL-3 Study)
Scientific title
Determining the optimal dose of omega-3 fatty acids in pregnancy for women with moderate status
Secondary ID [1] 310384 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The OPAL-3 Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 331127 0
Condition category
Condition code
Reproductive Health and Childbirth 327911 327911 0 0
Antenatal care
Reproductive Health and Childbirth 327912 327912 0 0
Normal pregnancy
Diet and Nutrition 328471 328471 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pregnant women with moderate omega-3 levels will be randomly assigned (like tossing a coin) to receive one of four doses of omega-3 supplements. Women allocated to each group will be asked to take 4 capsules per day.
The active capsules contain 200mg of DHA and 25 mg of EPA
The placebo or control capsules contain vegetable oil with no DHA and EPA.
Each treatment allocation will contain a different balance of active and control capsules.
Arm 1 - 4 control capsules per day - total of no DHA or EPA per day
Arm 2 - 1 active and 3 control capsules per day - total of 200 mg DHA, 25 mg EPA per day
Arm 3 - 2 active and 2 control capsules per day - total of 400 mg DHA, 50 mg EPA per day
Arm 4 - 4 active capsules per day - total of 800 mg DHA, 100 mg EPA per day
The supplementation period will be from study entry (estimated to be around 21 weeks of gestation) until 37 weeks of gestation or the birth of the baby, whichever comes first.
Intervention code [1] 326788 0
Treatment: Other
Comparator / control treatment
Placebo/control group -
Women allocated to the control group will also take 4 control capsules per day.
The composition of the control capsules will be made of a blend of 2 separate oils - corn and linseed oil - to match the fatty acid profile of Australian diet.
The control capsules contain no DHA or EPA.

There will also be 2 reference groups to benchmark omega-3 fatty acid status. These reference groups will not be allocated study supplements.
Reference group 1 - will include women with low omega-3 status (serum omega-3 <3.7% total fatty acids).
Reference group 2 - will include women with sufficient or replete status (serum omega-3 >4.3% total fatty acids).
Control group
Placebo

Outcomes
Primary outcome [1] 335762 0
Total omega-3 fatty acid level assessed using dried blood spots at 34-36 weeks gestation
Timepoint [1] 335762 0
34-36 weeks’ gestation
Secondary outcome [1] 425504 0
Baseline and mid-pregnancy Omega-3 levels fatty acid levels assessed using dried blood spots.
Timepoint [1] 425504 0
Baseline - < 21 weeks gestation
Mid-pregnancy - 26-28 weeks gestation
Secondary outcome [2] 427706 0
Gestational age at birth (length of gestation) as reported on the Health and Development Record’ booklet by the birthing hospital
Timepoint [2] 427706 0
4-6 weeks postpartum
Secondary outcome [3] 427707 0
Birth weight as reported on the Health and Development Record’ booklet by the birthing hospital
Timepoint [3] 427707 0
4-6 weeks postpartum
Secondary outcome [4] 427708 0
Birth length as reported on the Health and Development Record’ booklet by the birthing hospital.
Timepoint [4] 427708 0
4-6 weeks postpartum
Secondary outcome [5] 428323 0
Mode of delivery as reported on the Health and Development Record’ booklet by the birthing hospital
Timepoint [5] 428323 0
4-6 weeks postpartum

Eligibility
Key inclusion criteria
• Singleton pregnancy < 21 weeks gestation
• Able to give informed consent
Randomised Controlled Trial (RCT) Groups only:
• Identified as having an omega-3 fatty acid status in the lower end of the moderate range (defined as 3.7% to 4.0%% total fatty acids in serum)
Reference groups only:
Women with low omega-3 status (serum omega-3 <3.7% total fatty acids and supplemented with 800mg DHA + 100mg EPA per day)
OR Women with sufficient or replete status (serum omega-3 >4.3% total fatty acids) and taking no more than 250 mg per day of omega-3 from supplements.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Allergy to fish
• Enrolled in another fatty acid intervention trial throughout pregnancy.
• Currently taking heparin (Clexane)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2023
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 314584 0
Commercial sector/Industry
Name [1] 314584 0
Nestle
Country [1] 314584 0
Singapore
Funding source category [2] 315043 0
Government body
Name [2] 315043 0
National Health and Medical Research Council
Country [2] 315043 0
Australia
Primary sponsor type
Other Collaborative groups
Name
South Australian Health and Medical Research Institute
Address
SAHMRI, North Terrace Adelaide South Australia, AUSTRALIA 5000
Country
Australia
Secondary sponsor category [1] 317067 0
None
Name [1] 317067 0
Address [1] 317067 0
Country [1] 317067 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313619 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 313619 0
Ethics committee country [1] 313619 0
Australia
Date submitted for ethics approval [1] 313619 0
Approval date [1] 313619 0
24/07/2023
Ethics approval number [1] 313619 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128770 0
Prof Maria Makrides
Address 128770 0
South Australian Health and Medical Research Institute (SAHMRI) North Terrace Adelaide, SA 5000
Country 128770 0
Australia
Phone 128770 0
+61 08 8128 4501
Fax 128770 0
Email 128770 0
[email protected]
Contact person for public queries
Name 128771 0
Kimberley Hamlyn
Address 128771 0
SAHMRI, North TerraceAdelaide, SA 5000
Country 128771 0
Australia
Phone 128771 0
+61 0431 192 339
Fax 128771 0
Email 128771 0
[email protected]
Contact person for scientific queries
Name 128772 0
Maria Makrides
Address 128772 0
SAHMRI, North TerraceAdelaide, SA 5000
Country 128772 0
Australia
Phone 128772 0
+61 08 8128 4501
Fax 128772 0
Email 128772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data may be shared after de-identification upon reasonable request.
When will data be available (start and end dates)?
From publication of results to 5 years after publication.
Available to whom?
To gain access, data requestors will need to sign a data access agreement. Proposals to access the data must be scientifically and methodologically sound and must be reviewed and approved by the Steering Committee and a certified paediatric Human Research Ethics Committee, recognised under the National Mutual Acceptance (NMA) scheme.
Available for what types of analyses?
Proposals to access the data must be scientifically and methodologically sound and must be reviewed and approved by the Steering Committee and a certified paediatric Human Research Ethics Committee, recognised under the National Mutual Acceptance (NMA) scheme. The data must only be used for the analyses detailed in the aims of the approved proposal.
How or where can data be obtained?
Proposals should be directed to Professor Maria Makrides, Principal Investigator, [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20067Study protocolDetails to be added when available.   



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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