ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001078347

Ethics application status

Approved

Date submitted

20/07/2017

Date registered

25/07/2017

Date last updated

17/01/2023

Date data sharing statement initially provided

17/01/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Fish oil in pregnancy for a healthy start to life for the children of overweight mothers

Scientific title

Double-blind RCT of fish oil supplementation in pregnancy and lactation to improve metabolic health in the children of mothers with overweight or obesity

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1199-5860

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Maternal obesity

Childhood obesity

Metabolic dysfunction in childhood

Condition category

Condition code

Metabolic and Endocrine

Other metabolic disorders

Diet and Nutrition

Obesity

Reproductive Health and Childbirth

Antenatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

6 x 1g capsules of n-3 PUFA rich fish oil will be taken on each day of pregnancy and for 3 months during the breastfeeding period. Note that if the mother chooses to stop breastfeeding then supplementation will stop early, this will be at birth if the mother decides not to breastfeed at all. Compliance will be assessed by return of unused capsules, and secondarily by measurement of n-3 PUFA levels in maternal red blood cells. Note that the expected concentration of n-3 PUFAs in this oil is 33% EPA/22% DHA, but this will be independently verified. The expected dose of n-3 PUFAs (EPA and DHA) is 3g/day.

Intervention code [1]

Treatment: Other

Intervention code [2]

Prevention

Comparator / control treatment

6 grams of olive oil taken in capsules on each day of pregnancy and for 3 months during the breastfeeding period (if the mother chooses to breastfeed)

Control group

Placebo

Outcomes

Primary outcome [1]

Whole body percentage body fat (excluding head), as measured by dual x-ray absorptiometry (DXA) scan (in the offspring)

Timepoint [1]

2 weeks of age

Secondary outcome [1]

Birth Weight, measured in the delivery room using an infant scale

Timepoint [1]

At birth

Secondary outcome [2]

Whole body percentage body fat (excluding head), as measured by dual x-ray absorptiometry (DXA) scan (in the offspring)

Timepoint [2]

at 3 months of age

Secondary outcome [3]

Calculated from insulin and glucose measured from a fasting blood sample.

Timepoint [3]

3 months of age

Secondary outcome [4]

Weight measured using an infant scale

Timepoint [4]

2 weeks, 3 months and 12 months of age

Secondary outcome [5]

HOMA-IR calculated from maternal fasting insulin and glucose concentration

Timepoint [5]

At 30 weeks of pregnancy

Secondary outcome [6]

Ponderal index in the offspring calculated from length and weight

Timepoint [6]

2 weeks, 3 months and 12 months of age

Secondary outcome [7]

Insulin sensitivity as determined by a modified IVGTT with minimal modelling (offspring)

Timepoint [7]

4-7 years of age

Secondary outcome [8]

Hair cortisol measurement

Timepoint [8]

2 weeks of infant age

Secondary outcome [9]

Stool sample from infant for microbiome analysis

Timepoint [9]

2 weeks of age

Secondary outcome [10]

Whole body percentage body fat of the infant measured by bioimpedance spectroscopy analysis

Timepoint [10]

12 months

Secondary outcome [11]

Complementary food frequency questionnaire to assess infant feeding patterns

Timepoint [11]

12 months

Secondary outcome [12]

HOMA-IR calculated from glucose and insulin concentration in umbilical cord blood, sample taken by the lead maternal carer at birth.

Timepoint [12]

Birth

Secondary outcome [13]

Maternal body mass index calculated from height and weight (weight measured using a Wedderburn digital scale, height measured using a Harpenden stadiometer)

Timepoint [13]

30 weeks of gestation, 2 weeks after birth and 3 months after birth.

Secondary outcome [14]

Maternal blood pressure (sitting), systolic and diastolic. It will be measured using an automatic oscillometric sphygmomanometer.

Timepoint [14]

30 weeks of pregnancy as well as 2 weeks and 3 months

Secondary outcome [15]

Dietary PUFA intake using the New Zealand PUFA semi-quantitative food frequency questionnaire (for the mother)

Timepoint [15]

30 weeks of pregnancy, 2 weeks and 3 months of infant age.

Secondary outcome [16]

Edinburgh Postnatal Depression Scale (for the mother)

Timepoint [16]

30 weeks of gestation, 2 weeks, 3 months and 12 months of infant age

Secondary outcome [17]

International Physical Activity Questionnaire Long Form (for the mother)

Timepoint [17]

30 weeks of gestation, 2 weeks and 3 months of infant age.

Secondary outcome [18]

SF12 Health Related Quality of Life questionnaire (for the mother)

Timepoint [18]

30 weeks of gestation, 2 weeks and 3 months of infant age.

Secondary outcome [19]

Breast milk analysis for EPA + DHA concentration (a composite outcome)

Timepoint [19]

2 weeks and 3 months of infant age.

Secondary outcome [20]

Birth Length, measured using a paper tape measure.

Timepoint [20]

At birth

Secondary outcome [21]

Birth Head Circumference, measured using a paper tape measure

Timepoint [21]

At birth

Secondary outcome [22]

Birth Body Mass Index Calculated from Birth Length and Weight. Birth length and weight will be extracted from the infant Well Child Book, or the Birth discharge summary. Both will have been measured by the health staff involved in the routine initial care/assessment of the child, e.g. the midwife, hospital nurse, or paediatric doctor. It is expected that length will have been measured supine using a paper tape measure, while weight will be assessed using digital scales.

Timepoint [22]

At Birth

Secondary outcome [23]

Infant triglyceride concentration measured in fasting blood

Timepoint [23]

3 months of infant age

Secondary outcome [24]

Infant length measured using a lying neonatometer (at 2 weeks and 3 months) and a lying infantometer (at 12 months) of age.

Timepoint [24]

2 weeks, 3 months, 12 months of infant age

Secondary outcome [25]

Infant head circumference measured using a paper tape measure

Timepoint [25]

2 weeks, 3 months, 12 months of infant age

Secondary outcome [26]

Abdominal circumference measured using a paper tape measure

Timepoint [26]

2 weeks, 3 months, 12 months of infant age

Secondary outcome [27]

Infant body mass index calculated from length and weight.
Length will be measured using a neonatometer or infant stadiometer. Weight will be measured using digital scales.

Timepoint [27]

2 weeks, 3 months and 12 months of infant age

Secondary outcome [28]

Chest circumference measured using a paper tapemeasure

Timepoint [28]

12 months of infant age

Secondary outcome [29]

Mid-arm circumference measured using a paper tape measure

Timepoint [29]

12 months of age

Secondary outcome [30]

Triceps skinfold thickness measured using a Holtain skin fold caliper

Timepoint [30]

12 months of infant age

Secondary outcome [31]

Subscapular skinfold thickness measured using a Holtain skin fold caliper.

Timepoint [31]

12 months of age

Secondary outcome [32]

Maternal fasting glucose concentration

Timepoint [32]

30 weeks of pregnancy

Secondary outcome [33]

maternal fasting insulin concentration

Timepoint [33]

30 weeks of pregnancy

Secondary outcome [34]

maternal fasting triglyceride concentration

Timepoint [34]

30 weeks of pregnancy

Secondary outcome [35]

Maternal HbA1c from blood

Timepoint [35]

30 weeks of pregnancy

Secondary outcome [36]

omega-3 index measured from maternal red blood cells

Timepoint [36]

30 weeks of pregnancy

Secondary outcome [37]

Umbilical cord blood omega-3 index from red blood cells. This will be measured in a cord blood sample taken by the lead maternal carer at the time of birth.

Timepoint [37]

Birth

Secondary outcome [38]

Umbilical cord blood c-peptide concentration. Measured from a cord blood sample taken by the lead maternal carer at birth.

Timepoint [38]

Birth

Eligibility

Key inclusion criteria

Pregnant women, with BMI >=25, singleton pregnancy, between 12-20 weeks of gestation

Minimum age

18 Years

Maximum age

40 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Current use of tobacco or nicotine, illicit drugs or medications that influence blood pressure, lipid metabolism or insulin sensitivity. Having diabetes mellitus or chronic illnesses such as autoimmune disease or malignancy.

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)

Allocation will involve contacting the holder of the allocation schedule who is not involved in recruitment, carrying out or analyzing the study.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software

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

Parallel

Other design features

A previous update stated "Women who develop gestational diabetes will exit the study at the time of diagnosis of GDM and will not have any further assessments of themselves or their baby". This has been reversed. Women who develop gestational diabetes will not exit the study. Their babies will still receive all assessments and be included in the final analysis

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Treatment evaluation will be based on intention to treat. General linear regression models will be used to evaluate the treatment effect on the primary outcome and other offspring measures between the two treatment groups, adjusting for maternal age, BMI and parity at study entry, gestational age at birth, and offspring sex and age. Statistical analyses will be performed in SAS v9.4 (SAS Institute Inc., Cary, NC, USA). Statistical tests will be two-tailed and significance maintained at 5%, without adjustment for multiple testing. Missing data will be imputed for analysis of the primary outcome. Secondary analyses of data for which there are multiple measures over time e.g infant auxology and body composition, will use linear mixed models based on repeated measures.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

1/03/2018

Actual

29/03/2018

Date of last participant enrolment

Anticipated

1/10/2018

Actual

2/02/2020

Date of last data collection

Anticipated

1/04/2026

Actual

Sample size

Target

160

Accrual to date

Final

129

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

A Better Start National Science Challenge, Funded by the Ministry of Business, Innovation and Employment

Address [1]

Ministry of Business, Innovation and Employment
PO Box 1473
Wellington 6140

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Cure Kids

Address [2]

PO Box 90 907
Victoria Street West
Auckland 1142

Country [2]

New Zealand

Funding source category [3]

Government body

Name [3]

Health Research Council

Address [3]

PO Box 5541
Wellesley Street
Auckland 1141

Country [3]

New Zealand

Primary sponsor type

University

Name

Liggins Institute, University of Auckland

Address

Private bag 92019
Victoria Street West
Auckland 1142

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committees (New Zealand)

Ethics committee address [1]

Ministry of Health
 Health and Disability Ethics Committees
 PO Box 5013
 Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/08/2017

Approval date [1]

03/10/2017

Ethics approval number [1]

Summary

Brief summary

In New Zealand the majority of men (71%) and women (60%) are now overweight or obese. Obesity leads to cardiovascular disease, type 2 diabetes and some cancers, which are among the world’s greatest health problems. Within NZ, Maori, Pasifika and those who are poorer are more greatly affected.

Most women of reproductive age are also overweight or obese (60%). This is important as the offspring of women who are obese have alterations in the way their metabolism works that increase the chance that they will be a large baby, become overweight and eventually develop diabetes and cardiovascular disease. When these babies are born, they are already at a health disadvantage. The underlying problem is that insulin, the hormone that controls blood sugar works less well in their bodies. 

I have shown in rats, that supplementing obese mothers with fish oil can prevent the offspring from developing problems with insulin action as they age. If this treatment had the same effect in humans, pregnant women could use it to reduce their unborn child’s lifetime risk of disease. This is a treatment that is already easily available in stores, so that it would be easy for women to take up.

We will enrol women into a clinical trial where they are randomised to take either fish oil, or a placebo (capsules with ordinary olive oil) on every day of pregnancy and the first 3 months of breastfeeding. When the baby is born we will measure its body fat using a special scan (at two weeks of age). We will reassess the baby again at 3 months and 12 months of age. We will keep in contact over time, and when the child is 4-7 years old we will perform a detailed assessment of the child’s metabolism, including assessing insulin action.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Benjamin Albert

Address

Liggins Institute, University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142

Country

New Zealand

Phone

+64 9 923 6691

Fax

+64 9 373 8763

b.albert@auckland.ac.nz

Contact person for public queries

Name

Benjamin Albert

Address

Liggins Institute, University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142

Country

New Zealand

Phone

+64 9 923 6691

Fax

+64 9 373 8763

b.albert@auckland.ac.nz

Contact person for scientific queries

Name

Benjamin Albert

Address

Liggins Institute, University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142

Country

New Zealand

Phone

+64 9 923 6691

Fax

+64 9 373 8763

b.albert@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

The written consent form approved by the HDEC ethics committee and signed by all participants did not grant permission to publish individual participant data. Permission was granted for anonymised group analyses, which will be published in scientific journals

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
18063	Study protocol	Satokar VV, Cutfield WS, Derraik JG, Harwood M, Okasene-Gafa K, Beck K, Cameron-Smith D, O’Sullivan JM, Sundborn G, Pundir S, Mason RP. Double-blind RCT of fish oil supplementation in pregnancy and lactation to improve the metabolic health in children of mothers with overweight or obesity during pregnancy: study protocol. BMJ open. 2020 Dec 1;10(12):e041015.	https://bmjopen.bmj.com/content/10/12/e041015.abstract			373332-(Uploaded-13-01-2023-08-19-37)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Double-blind RCT of fish oil supplementation in pregnancy and lactation to improve the metabolic health in children of mothers with overweight or obesity during pregnancy: Study protocol.	2020	https://dx.doi.org/10.1136/bmjopen-2020-041015
Embase	Fish oil supplementation during pregnancy and postpartum in mothers with overweight and obesity to improve body composition and metabolic health during infancy: A double-blind randomized controlled trial.	2023	https://dx.doi.org/10.1016/j.ajcnut.2023.02.007

N.B. These documents automatically identified may not have been verified by the study sponsor.

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