ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000053426

Ethics application status

Approved

Date submitted

15/01/2016

Date registered

20/01/2016

Date last updated

6/06/2019

Date data sharing statement initially provided

6/06/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Can omega-3 fatty acids reduce cardiovascular risk in children born with poor fetal growth: the Small baby Omega-3 (SO3) trial

Scientific title

Effects of omega-3 fatty acid supplementation to improve cardiovascular risk markers in children born small-for-gestational-age.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1178-5213

Trial acronym

SO3 trial

Linked study record

Health condition

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

Small-for-gestational-age

Increased aortic intima-media thickness

Hypertension

Condition category

Condition code

Cardiovascular

Hypertension

Reproductive Health and Childbirth

Childbirth and postnatal care

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will be randomized into groups to either the fish oil supplement (intervention) or no supplement (control) group from 6 months to 18 months of age.
The fish oil supplement will be provided to participants when infants are 6 months old in an encapsulated form containing 300 mg of omega-3 marine triglycerides (EPA 45mg, DHA 150mg), at a dose designed to achieve an omega-3 index of 8%, the optimum level for cardiovascular health. Parents/guardians will cleave the tail end of the capsule to dispense the liquid content into the infant's food or beverage.
Compliance will be measured by assessing blood fatty acid status and empty supplement bottle return.

Intervention code [1]

Prevention

Comparator / control treatment

The control group will not receive a supplement.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Aortic intima-media thickness using an ultrasound machine

Timepoint [1]

Aortic intima-media thickness will be measured at birth (enrolment), 6, 12, 18 months of age. The primary timepoint will be at 18 months of age.

Secondary outcome [1]

Systolic blood pressure using an automated device (CARESCAPE v100)

Timepoint [1]

Systolic blood pressure will be measured at birth (enrolment), 6, 12 and 18 months of age. The primary timepoint will be at 18 months of age.

Secondary outcome [2]

Infant weight will be measured as an exploratory outcome. Birth weight will be recorded from the patient medical records. Infant weight at 6, 12 and 18 months will be measured using digital scales (Seca 385 Infant Scales, Hamburg, Germany) from children wearing light clothes, no nappies and no shoes.

Timepoint [2]

Weight will be measured at birth (enrolment), 6, 12 and months of age as an exploratory outcome.

Secondary outcome [3]

Infant height will be measured as an exploratory outcome

Timepoint [3]

Infant's height will be measured at enrolment, 6, 12 and 18 months of age. Two length measurements will be taken supine (Seca 217 Infant Measuring Board, Hamburg, Germany) on a level floor and recorded to the nearest 0.1 cm.

Secondary outcome [4]

Autonomic control (heart rate variability) will be measured as an exploratory outcome where heart rate will be recorded using a 3-lead ECG over a total of 15 minutes. Heart rate variability will be determined using the Lab Chart software (version 8, AD Instruments, Australia).

Timepoint [4]

Autonomic control will be measured at enrolment, 6, 12 and 18 months of age.

Secondary outcome [5]

Cardiac structure and function will be measured as an exploratory outcome using an ultra sound machine

Timepoint [5]

Cardiac structure and function will be assessed at enrolment, 6 and 18 months of age

Eligibility

Key inclusion criteria

Infants born at term (>37 weeks gestation) that are small-for-gestational-age (birth weight<10th percentile for sex and gestational age).

Minimum age

No limit

Maximum age

2 Weeks

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Multiple births, infants requiring surgery, illness in infant requiring hospitalization for more than 2 weeks, infants with significant neonatal disease, infants with chromosomal abnormalities or congenital malformations, fish oil contraindicated in mother.

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 computerized randomization system

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

Intervention assignment will be via a central computerized system using minimization to balance treatment allocation with respect to hospital, newborn gender, ethnicity (Caucasian; non-Caucasian), gestational age (37-39 weeks; <40 weeks), and birth weight percentile (<3rd percentile; 3rd-10th percentile).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Given a sample size of 252 participants in each randomized group, and type I error probability of 0.05, this study will have: 88% power to detect a clinically relevant relative reduction in aortic IMT of 0.021 mm; 80% power to detect a population relevant 2.5 mm Hg reduction in systolic blood pressure in the omega-3 intervention group; and greater than 95% power to detect a clinically relevant 3.8 mm Hg reduction in systolic blood pressure. Based on our previous experience, we assume a 12.5% loss to follow-up at age 2 years. Thus, we need to randomize 288 participants per group (576 total).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

28/02/2017

Actual

31/01/2018

Date of last participant enrolment

Anticipated

28/01/2020

Actual

Date of last data collection

Anticipated

1/12/2020

Actual

Sample size

Target

576

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

The Children's Hospital at Westmead - Westmead

Recruitment postcode(s) [1]

2006 - The University Of Sydney

Recruitment postcode(s) [2]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders
D17 The Hub, Charles Perkins Centre
The University of Sydney, Camperdown,
NSW, 2006

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

The Children's Hospital at Westmead

Address [1]

The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St Westmead,
NSW 2145

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

University of Turku

Address [1]

Research Centre of Applied and Preventative Cardiovascular Medicine,
University of Turku
Kiinamyllynkatu 10
20520 Turku

Country [1]

Finland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Lower Health District Ethics Commirttee (Royal Prince Alfred Hospital Zone)

Ethics committee address [1]

Research Development Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/02/2015

Approval date [1]

24/09/2015

Ethics approval number [1]

Summary

Brief summary

Low birth weight is an important risk factor for adult ischemic heart disease. Those born small-for-gestational-age (<10th percentile for gestational age and gender) are at the highest risk for adult cardiovascular disease. Children and adults born small for gestational age have increased arterial intima-media thickness – a noninvasive marker of subclinical atherosclerosis, the underlying disease process responsible for the majority of cardiovascular events. Birth weight is inversely associated with blood pressure – a major cardiovascular risk factor, in both children and adults. 
Published data from populations of children and young adults suggest that omega-3 fatty acid supplementation will have beneficial effects in reducing arterial intima-medial thickness and systolic blood pressure in children who were born small for gestational age. This hypothesis has not been tested in a randomized controlled trial. 
This study is designed to test the effectiveness of omega-3 fatty acid supplementation from 6 to 18 months of age in reducing aortic intima-media thickness and systolic blood pressure in children born small-for-gestational-age. The study will be conducted as an open label randomized controlled trial over a 1 year intervention (when the infant is 6-18 months old) where aortic intima media thickness and systolic blood pressure will be measured at recruitment, 6, 12 and 18 months of age.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Michael Skilton

Address

Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders
D17 The Hub, Charles Perkins Centre
The University of Sydney, Camperdown,
NSW, 2006

Country

Australia

Phone

+61 2 8627 1916

Fax

michael.skilton@sydney.edu.au

Contact person for public queries

Name

Jovana Mijatovic

Address

Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders
D17 The Hub, Charles Perkins Centre
The University of Sydney, Camperdown,
NSW, 2006

Country

Australia

Phone

+61 286271341

Fax

jovana.mijatovic@sydney.edu.au

Contact person for scientific queries

Name

Michael Skilton

Address

Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders
D17 The Hub, Charles Perkins Centre
The University of Sydney, Camperdown,
NSW, 2006

Country

Australia

Phone

+61 2 8627 1916

Fax

michael.skilton@sydney.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

When the study was initially conceptualised, participants were informed that "only the (listed) researchers....., the research assistants and research midwives working on this study will have access" to participant data.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Results are not ready as the study is still active... [More Details]

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No additional documents have been identified.

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