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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]

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

Condition category

Condition code

Diet and Nutrition

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]

Prevention

Comparator / control treatment

3 x 500mg blended vegetable oil capsules per day

Control group

Placebo

Outcomes

Primary outcome [1]

Percentage body fat mass as assessed by Air Displacement Plethsmography (ADP

Timepoint [1]

Seven years of age

Secondary outcome [1]

Percentage body fat mass as assessed by Bioelectical Independence Spectroscopy (BIS)

Timepoint [1]

Seven years of age

Secondary outcome [2]

Body Mass Index (BMI) z-score

Timepoint [2]

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)

Recruitment hospital [1]

Womens and Childrens Hospital - North Adelaide

Recruitment hospital [2]

Flinders Medical Centre - Bedford Park

Recruitment hospital [3]

Flinders Private Hospital - Bedford Park

Recruitment postcode(s) [1]

5006 - North Adelaide

Recruitment postcode(s) [2]

5042 - Bedford Park

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Adelaide

Address [1]

North Terrace
Adelaide
SA 5005

Country [1]

Australia

Primary sponsor type

University

Name

The University of Adelaide

Address

North Terrace
Adelaide
SA 5005

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Women's & Children's Health Research Institute

Address [1]

Women's & Children's Health Research Institute
72 King William Road
North Adelaide
SA 5006

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's & Children's Health Network

Ethics committee address [1]

Women's & Children's Health Network
72 King William Street
North Adelaide
SA 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/11/2013

Approval date [1]

05/02/2014

Ethics approval number [1]

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

A/Prof Beverly Muhlhausler

Address

FOODplus Research Centre
School of Agriculture, Food and Wine
The University of Adelaide
Waite Campus
Waite Road
Urrbrae
SA 5064

Country

Australia

Phone

+61 (08) 8313 0848

Fax

+61 (08) 8313 7135

beverly.muhlhausler@adelaide.edu.au

Contact person for public queries

Name

Beverly Muhlhausler

Address

FOODplus Research Centre
School of Agriculture, Food and Wine
The University of Adelaide
Waite Campus
Waite Road
Urrbrae
SA 5064

Country

Australia

Phone

+61 (08) 8313 0848

Fax

+61 (08) 8313 7135

beverly.muhlhausler@adelaide.edu.au

Contact person for scientific queries

Name

Beverly Muhlhausler

Address

FOODplus Research Centre
School of Agriculture, Food and Wine
The University of Adelaide
Waite Campus
Waite Road
Urrbrae
SA 5064

Country

Australia

Phone

+61 (08) 8313 0848

Fax

+61 (08) 8313 7135

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

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