Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001127998
Ethics application status
Approved
Date submitted
26/09/2011
Date registered
27/10/2011
Date last updated
12/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The 3 and 5 year follow up of children who participated in the DOMInO study: growth and insulin resistance follow-up.
Scientific title
The 3 and 5 year follow up of children who participated in the DOMInO study: does maternal supplementation with n-3 long-chain PUFA in pregnancy influence child growth and insulin resistance?
Secondary ID [1] 252219 0
none
Universal Trial Number (UTN)
Trial acronym
The ChOIR Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
growth 257741 0
insulin resistance 279046 0
Condition category
Condition code
Diet and Nutrition 257915 257915 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a follow up from the original DOMInO Study: ACTRN12605000569606.
3 x 0.5 DHA rich Tuna Oil Capsules taken daily from 18-21 weeks until birth of child in The DOMInO Study.
Intervention code [1] 269453 0
Prevention
Comparator / control treatment
0.5g Blended Vegetable Oil Capsules
Control group
Placebo

Outcomes
Primary outcome [1] 279696 0
The effect of maternal dietary supplementation with n-3 LCPUFA in pregnancy on the percentage body fat in children at 3 and 5 years of age, using Body Mass Index and Bioelectrical impedance analysis.
Timepoint [1] 279696 0
3 and 5 years
Secondary outcome [1] 294236 0
Insulin sensitivity in children at 3 and 5 years of age by assessing HOMA-IR
Timepoint [1] 294236 0
3 and 5 years

Eligibility
Key inclusion criteria
All children from the original DOMInO trial enrolled from the South Australian recruitment sites.
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

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 and mail
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2009
Actual
25/03/2009
Date of last participant enrolment
Anticipated
Actual
4/10/2013
Date of last data collection
Anticipated
Actual
4/10/2013
Sample size
Target
1619
Accrual to date
Final
1531
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 269933 0
Government body
Name [1] 269933 0
NH&MRC
Country [1] 269933 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] 268934 0
None
Name [1] 268934 0
Address [1] 268934 0
Country [1] 268934 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271900 0
Women's and Children's Health Network
Ethics committee address [1] 271900 0
Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006
Ethics committee country [1] 271900 0
Australia
Date submitted for ethics approval [1] 271900 0
Approval date [1] 271900 0
15/01/2009
Ethics approval number [1] 271900 0
11/11/2123

Summary
Brief summary
The primary aim of the study is to determine the effect of maternal dietary supplementation with n-3 LCPUFA in pregnancy on the percentage body fat in children at 3 and 5 years of age.

the pathway to obesity begins early in life, and reducing this early accumulation of excess body fat represents an essential strategy for improving health outcomes across the life course.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31393 0
Prof Maria Makrides
Address 31393 0
Women's and Children's Health Research Institute
Level 7, CRB Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006
Country 31393 0
Australia
Phone 31393 0
+61 (0)8 8161 6067
Fax 31393 0
+61 (0)8 8239 0267
Email 31393 0
maria.makrides@health.sa.gov.au
Contact person for public queries
Name 14640 0
Ms Helen Loudis
Address 14640 0
Child Nutrition Research Centre
Flinders Medical Centre
Flinders Drive
BEDFORD PARK SA 5042
Country 14640 0
Australia
Phone 14640 0
+61 8 82045515
Fax 14640 0
+61 8 82046296
Email 14640 0
helen.loudis@health.sa.gov.au
Contact person for scientific queries
Name 5568 0
Dr Beverly Muhlhausler
Address 5568 0
Waite Campus, The University of Adelaide
PMB 1, GLEN OSMOND, SA 5064
Country 5568 0
Australia
Phone 5568 0
+61 8 8313 0848
Fax 5568 0
+61 8 8303 7135
Email 5568 0
Beverly.Muhlhausler@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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDHA supplementation during pregnancy does not reduce BMI or body fat mass in children: Follow-up of the DHA to Optimize Mother Infant Outcome randomized controlled trial.2016https://dx.doi.org/10.3945/ajcn.115.126714
N.B. These documents automatically identified may not have been verified by the study sponsor.