Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000404325
Ethics application status
Approved
Date submitted
16/03/2017
Date registered
20/03/2017
Date last updated
20/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does maternal omega-­3 fatty acid supplementation reduce body fat mass at 7 years of age?
Scientific title
Assessing the impact of maternal supplementation with omega-3 long chain polyunsaturated fatty acids (n-3 LCPUFA) on the body composition of children at 7 years of age using Air Displacement Plethysmography (ADP)
Secondary ID [1] 291452 0
Nil
Universal Trial Number (UTN)
Trial acronym
DOMInO BOD-POD Study
Linked study record
ACTRN12605000569606
ACTRN12611001127998

Health condition
Health condition(s) or problem(s) studied:
Overweight and Obesity 302486 0
Condition category
Condition code
Diet and Nutrition 302046 302046 0 0
Obesity

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 (800mg DHA and 100mg EPA/day) from 18-21 weeks gestation until birth of child.
Intervention code [1] 297499 0
Prevention
Comparator / control treatment
3 x 500mg blended vegetable oil capsules per day
Control group
Placebo

Outcomes
Primary outcome [1] 301467 0
Percentage body fat mass as assessed by Air Displacement Plethsmography (ADP
Timepoint [1] 301467 0
Seven years of age
Secondary outcome [1] 332753 0
Percentage body fat mass as assessed by Bioelectical Independence Spectroscopy (BIS)
Timepoint [1] 332753 0
Seven years of age
Secondary outcome [2] 332754 0
Body Mass Index (BMI) z-score
Timepoint [2] 332754 0
Seven years of age

Eligibility
Key inclusion criteria
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 supplementation. DOMInO women were eligible for this follow-up if they had been enrolled in Adelaide centres, and were able and willing to attend a clinic appointment in metropolitan Adelaide when their child was between 7 and 8 years of age
Minimum age
7 Years
Maximum age
8 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
Actual
14/04/2014
Date of last participant enrolment
Anticipated
Actual
28/05/2015
Date of last data collection
Anticipated
Actual
28/05/2015
Sample size
Target
350
Accrual to date
Final
252
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7672 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 7673 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 7674 0
Flinders Private Hospital - Bedford Park
Recruitment postcode(s) [1] 15591 0
5006 - North Adelaide
Recruitment postcode(s) [2] 15592 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 295919 0
University
Name [1] 295919 0
The University of Adelaide
Country [1] 295919 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace
Adelaide
SA 5005
Country
Australia
Secondary sponsor category [1] 294793 0
Other
Name [1] 294793 0
Women's & Children's Health Research Institute
Address [1] 294793 0
Women's & Children's Health Research Institute
72 King William Road
North Adelaide
SA 5006
Country [1] 294793 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297199 0
Women's & Children's Health Network
Ethics committee address [1] 297199 0
Women's & Children's Health Network
72 King William Street
North Adelaide
SA 5006
Ethics committee country [1] 297199 0
Australia
Date submitted for ethics approval [1] 297199 0
13/11/2013
Approval date [1] 297199 0
05/02/2014
Ethics approval number [1] 297199 0
HREC/13/WCHN168

Summary
Brief summary
Docosahexaenoic acid (DHA) is an n­3 long chain polyunsaturated fatty acid (LCPUFA) which is important for optimum health of the mother and growth and development of the fetus. During the prenatal period, the time before birth, the only source of LCPUFAs for the fetus is from the mother via transfer across the placenta. The last trimester of gestation is the major period of n­3 LCPUFA accumulation in fetal tissues, including fetal fat tissue. The n­3 LCPUFAs inhibit fat cell formation and lipid accumulation in adults and this has led to the suggestion that prenatal exposure to an increased supply of n­3 LCPUFA could reduce the subsequent accumulation of fat tissue in childhood, and hence the risk of obesity and diabetes later in life. However, results of the studies which have attempted to study this question to date have been inconclusive.

The DOMInO trial (DHA to Optimise Mother Infant Outcome) was designed to evaluate the effects of supplementing women with 800mg DHA/day during the second half of pregnancy on maternal and infant outcomes. The growth andinsulin resistance follow­up of children in this study was undertaken when they were 3 and 5 years old and aimed to determine whether increasing the amount of n­3 LCPUFA in the diet during pregnancy could reduce the risk of obesity and diabetes in the children. In the present study, we are proposing to extend this follow­up of the DOMInO children to 7 years of age. This is important, since major changes in body composition (the balance of muscle and fat) occur in the first few years after children start school. Capturing the growth and body composition of the DOMInO children at 7 years of age will therefore provide a more complete picture of changes in body composition over this critical period of growth and will enable us to determine the effects of maternal n­3 LCPUFA supplementation on the body fat mass at school age. The body fat mass of children at school age is also a stronger predictor of their body fat mass and metabolic health later in development than fat mass at earlier ages.
The primary outcome of the current study is to assess if omega 3 LCPUFA supplementation during pregnancy is associated with a reduced body fat mass later in childhood. This will be achieved by measuring body composition and body mass index (BMI) z-scores in children (n=252) of mother's who were enrolled in the DOMInO trial at 7 years of age. The findings from this study will provide valuable information as to whether maternal n­3 LCPUFA supplementation in pregnancy has the potential to reduce body fat mass in children at school age, and therefore reduce their future risk of obesity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73318 0
A/Prof Beverly Muhlhausler
Address 73318 0
FOODplus Research Centre
School of Agriculture, Food and Wine
The University of Adelaide
Waite Campus
Waite Road
Urrbrae
SA 5064
Country 73318 0
Australia
Phone 73318 0
+61 (08) 8313 0848
Fax 73318 0
+61 (08) 8313 7135
Email 73318 0
beverly.muhlhausler@adelaide.edu.au
Contact person for public queries
Name 73319 0
A/Prof Beverly Muhlhausler
Address 73319 0
FOODplus Research Centre
School of Agriculture, Food and Wine
The University of Adelaide
Waite Campus
Waite Road
Urrbrae
SA 5064
Country 73319 0
Australia
Phone 73319 0
+61 (08) 8313 0848
Fax 73319 0
+61 (08) 8313 7135
Email 73319 0
beverly.muhlhausler@adelaide.edu.au
Contact person for scientific queries
Name 73320 0
A/Prof Beverly Muhlhausler
Address 73320 0
FOODplus Research Centre
School of Agriculture, Food and Wine
The University of Adelaide
Waite Campus
Waite Road
Urrbrae
SA 5064
Country 73320 0
Australia
Phone 73320 0
+61 (08) 8313 0848
Fax 73320 0
+61 (08) 8313 7135
Email 73320 0
beverly.muhlhausler@adelaide.edu.au

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