Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000498594
Ethics application status
Approved
Date submitted
24/04/2015
Date registered
19/05/2015
Date last updated
19/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Six year follow up of children at high hereditary risk of allergy born to mothers participating in the DOMInO Trial.
Scientific title
Six year follow up of a randomised controlled trial to compare
maternal omega-3 long chain poly-unsaturated fatty acids (n-3 LCPUFA) supplementation versus vegetable oil in pregnancy, on allergic disease outcomes in the school age child
Secondary ID [1] 286144 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
DOMInO 6
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopy & Allergic Disease 294154 0
Condition category
Condition code
Inflammatory and Immune System 294477 294477 0 0
Allergies
Alternative and Complementary Medicine 294478 294478 0 0
Other alternative and complementary medicine
Inflammatory and Immune System 294479 294479 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a follow up children born to women participating in the DOMInO Trial: ACTRN12605000569606. Women were asked to consume 3 x 500mg DHA rich Tuna Oil capsules daily from 18-21 weeks gestation until birth of child.
Intervention code [1] 291147 0
Prevention
Comparator / control treatment
3 x 500mg blended vegetable oil capsules per day
Control group
Placebo

Outcomes
Primary outcome [1] 294258 0
Incidence of allergic disease symptoms (eczema, allergic rhinitis or wheeze) with sensitisation (determined by a positive skin prick test to food allergens or aeroallergens) in the child.
Timepoint [1] 294258 0
Six years of age
Secondary outcome [1] 312889 0
Symptoms of individual allergic disease (eczema, allergic rhinitis or wheeze) with or without sensitisation in the child at 6 years of age. Sensitisation to individual allergen extracts.
Timepoint [1] 312889 0
Six years of age

Eligibility
Key inclusion criteria
Child was consented to nested 1 and 3 year allergy cohort of the DOMInO trial prior to birth with family history of medically diagnosed allergic disease (eczema, asthma, allergic rhinitis):
Women in DOMInO trial had singleton pregnancy less than 18-21 weeks gestation with no known fetal abnormality: mothers not to have had documented history of alcohol or drug abuse: no participation in other clinical trials with fatty acid
Minimum age
6 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Maternal bleeding disorders where DHA 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 randomisation service
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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/03/2012
Actual
10/04/2012
Date of last participant enrolment
Anticipated
22/08/2014
Actual
22/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
668
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3428 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 3429 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 9194 0
5006 - North Adelaide
Recruitment postcode(s) [2] 9195 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 291155 0
Government body
Name [1] 291155 0
National Health and Medical Research Council
Country [1] 291155 0
Australia
Primary sponsor type
Other
Name
Women's & Children's Health Research Institute
Address
Women's & Children's Health Research Institute
72 King William Road
North Adelaide
SA 5006
Country
Australia
Secondary sponsor category [1] 289833 0
None
Name [1] 289833 0
Address [1] 289833 0
Country [1] 289833 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292731 0
Women's & Children's Health Network
Ethics committee address [1] 292731 0
Women's & Children's Health Network
72 King William Street
North Adelaide
SA 5006
Ethics committee country [1] 292731 0
Australia
Date submitted for ethics approval [1] 292731 0
Approval date [1] 292731 0
12/01/2012
Ethics approval number [1] 292731 0
REC 2435/12/14
Ethics committee name [2] 292732 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [2] 292732 0
Flinders Medical Centre
Bedford Park
SA 5042
Ethics committee country [2] 292732 0
Australia
Date submitted for ethics approval [2] 292732 0
Approval date [2] 292732 0
11/04/2012
Ethics approval number [2] 292732 0
146.12

Summary
Brief summary
The aim of the 6 year allergy follow up is to see if taking fish oil supplements during pregnancy can reduce the development of allergies in children and how long these effects may last. At 1 year of age, we found that there were fewer children with atopic eczema and fewer children with a positive skin prick test to egg in the group whose mothers took fish oil supplements during pregnancy than those in the control group that took vegetable oil capsules. As children reach school age we expect asthma and hayfever to become more common and by examining all children at 6 years of age, we will be able see whether the effects of fish oil supplementation during pregnancy are long standing or are only seen in early childhood.
Trial website
www.sahmri.com/our-research/themes/healthy-mothers-babies-children/research/list
Trial related presentations / publications
Public notes
Find us on Facebook
www.facebook.com/CNRCAdelaide

Contacts
Principal investigator
Name 54814 0
Prof Maria Makrides
Address 54814 0
Women's & Children's Health Research Institute
72 King William Road
North Adelaide
SA 5006
Country 54814 0
Australia
Phone 54814 0
61 8 8161 7443
Fax 54814 0
Email 54814 0
maria.makrides@health.gov.au
Contact person for public queries
Name 54815 0
Ms Karen Best
Address 54815 0
Women's & Children's Health Research Institute
72 King William Road
North Adelaide
SA 5006
Country 54815 0
Australia
Phone 54815 0
+61434243404
Fax 54815 0
Email 54815 0
karen.best@adelaide.edu.au
Contact person for scientific queries
Name 54816 0
Ms Karen Best
Address 54816 0
Women's & Children's Health Research Institute
72 King William Road
North Adelaide
SA 5006
Country 54816 0
Australia
Phone 54816 0
+61434243404
Fax 54816 0
Email 54816 0
karen.best@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4508Study results articleYes Best KP, Sullivan T, Palmer D, et al. Prenatal Fis... [More Details] 367939-(Uploaded-07-02-2019-10-18-07)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.