ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001349336

Ethics application status

Approved

Date submitted

5/09/2017

Date registered

25/09/2017

Date last updated

3/12/2019

Date data sharing statement initially provided

3/12/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

The Breast Milk Omega-3 Trial: Assessing the uptake of a specific omega-3 supplement into breast milk

Scientific title

The Breast Milk Omega-3 Trial: Effect of high omega-3 supplementation of breastfeeding women on omega-3 fatty acid concentrations in breast milk

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1199-5378

Trial acronym

None

Linked study record

Health condition

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

maternal and infant health

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Reproductive Health and Childbirth

Breast feeding

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention capsule (High omega-3 oil blend)
Capsules of DHA enriched fish oil based high concentrated omega-3-acid oil formulation based on PronovaPure 150:500 EE EU. Each capsule contains 467 mg of omega-3 fatty acid ethyl esters (169 mg of EPA and 298 mg of DHA ethyl esters).
- each participant will be randomly assigned to either the control or intervention group
- participants will be asked to consume 2 oral capsules (1000mg per capsule, 2000mg total/day) per day for 4 weeks
Women will be asked to return unused supplements at the end of the study. The proportion of capsules returned will serve as a measure of adherence. Blood omega-3 concentrations at the end of intervention will be used as an independent biomarker of adherence.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control 1000mg capsule containing 100% olive oil (refined).
- each participant will be radomly assigned to either the control or intervention group
- participants will be asked to consume 2 oral capsules (1000mg per capsule, 2000mg total/day) per day for 4 weeks
Women will be asked to return unused supplements at the end of the study. The proportion of capsules returned will serve as a measure of adherence.

Control group

Placebo

Outcomes

Primary outcome [1]

Breast milk omega-3 fatty acid concentrations

Timepoint [1]

4 weeks after commencement of capsules (study end-point)

Secondary outcome [1]

Blood omega-3 fatty acids concentrations at the end of the intervention

Timepoint [1]

4 weeks after commencement of capsules (study end-point)

Secondary outcome [2]

Breast-milk omega-3 concentrations across the 4 week study period

Timepoint [2]

serial samples collected daily during the first week of the intervention and twice weekly across the final 3-weeks of the intervention period

Eligibility

Key inclusion criteria

-Singleton pregnancy
-Intending to or currently breastfeeding
-Willing to take capsules containing fish-oil
-Infant younger than 4 weeks or equal to older than 12 months of age

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

-Currently pregnant
-BMI greater than 40kg/m2
-Regularly taking high dose fish-oil supplements ( greater than 250mg DHA/day)
-Taking fish-oil supplements (less than or equal to 250mg DHA/day) and not willing to stop at least 4 weeks prior to commencing this study
-Bleeding disorder in which fish-oil is contraindicated
-Maternal diseases known to affect gastric absorption
-Participation in other RCTs involving omega-3 LCPUFA supplementation during lactation

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Each study pack will contain either treatment or control capsules, pre-packed according to the randomisation schedule. Participants and their family, care providers, outcome assessors and data analysts will be blinded to randomisation group.

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

Women will be assigned to study packs labelled with a unique study number assigned through a computer generated randomisation schedule which is prepared by an independent consultant.

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

Phase

Not Applicable

Type of endpoint/s

Bio-availability

Statistical methods / analysis

All analyses will be performed on an intention-to-treat basis. Separate per-protocol analyses will be conducted which only include women who consume at least 80% of their study capsules. Differences in the omega-3 LCPUFA content between the omega-3 LCPUFA and Control groups at the end of the intervention period will be compared by non-parametric and parametric tests as appropriate. The relative increase in omega-3 LCPUFA, as well as the pattern of omega-3 LCPUFA concentrations across this period will also be compared between groups using general linear models with repeated measures. A p value of less than 0.05 will be considered as the level of statistical significance in all analyses.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

10/08/2017

Date of last participant enrolment

Anticipated

24/11/2017

Actual

14/03/2018

Date of last data collection

Anticipated

22/12/2017

Actual

11/04/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

SA,VIC

Recruitment hospital [1]

Womens and Childrens Hospital - North Adelaide

Recruitment postcode(s) [1]

5006 - North Adelaide

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Pronova BioPharma

Address [1]

Grete Mørk KindbergRKindberg R&D Manager
Pronova BioPharma Norge AS
Lilleakerveien 2C, NO-0283 Oslo, Norway
PB 420 , 1327 Lysaker, Norway

Country [1]

Norway

Primary sponsor type

Commercial sector/Industry

Name

Pronova Biopharma

Address

Pronova BioPharma Norge AS
Lilleakerveien 2C, NO-0283 Oslo, Norway
PB 420 , 1327 Lysaker, Norway

Country

Norway

Secondary sponsor category [1]

University

Name [1]

The University of Adelaide

Address [1]

Floor/Room 4
Rundle Mall Plaza
North Terrace
Adelaide
SA 5005

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network HREC

Ethics committee address [1]

Research Secretariat 
Women’s and Children’s Hospital
Level 2 Samuel Way Building
72 King William Road
North Adelaide  SA  5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/03/2017

Approval date [1]

08/08/2017

Ethics approval number [1]

HREC/17/WCHN/37

Summary

Brief summary

Omega-3 fatty acids, in particular Docosahexaenoic acid (DHA) and Eicosapentaenoic acid (EPA) are known to play a critical role in both maternal health and infant development, and have a particularly important role in protection against preterm delivery and in ensuring the optimal development of the brain and visual system of the fetus and infant (Makrides & Gibson, Med J Aust, 2002; Demmelmair & Koletzko, World Rev Nutr Dietet, 2015). Achieving and maintaining an adequate supply of these fatty acids during pregnancy and breastfeeding is therefore of vital importance for both short and long term health outcomes of the infant. Recent studies have suggested that many women of childbearing age in many countries, including Australia and the US, fail to meet the recommended levels of intake of these fatty acids, and as a result have a low omega-3 status (Meyer, Nutrients, 2016). Therefore, there is a concern that a significant proportion of women have an insufficient omega-3 status during pregnancy and while breastfeeding in order to meet the needs of their infant. In addition, fish consumption in the majority of these countries also remains low, and therefore these women rely predominately on omega-3 supplements in order to increase their omega-3 status. It is also known, however, that the bioavailability of different supplements into human blood and breast milk can vary significantly according to the formulation and form in which the fatty acids are provided. This is particularly important in the case of women who are breastfeeding, since the uptake of supplements into breast milk depends on both the efficiency of uptake into the maternal circulation, and the transfer of these fatty acids to the breast milk. As such, it is vital to directly test the ability of supplements provided to lactating women to be taken up into the breast milk.
The primary objective of this study is to assess the effect of supplementing breastfeeding women with the Pronovum formulation PRF-037 (150:500 Ethyl Ester in SMEDDS) on concentrations of DHA and EPA in breast milk after 4 weeks of supplementation.

Trial website

https://www.sahmriresearch.org/our-research/themes/healthy-mothers-babies-children/research-list

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Beverly Muhlhausler

Address

FOODplus Research Centre
Waite Campus, The University of Adelaide
PMB 1, GLEN OSMOND, SA 5064

Country

Australia

Phone

+61 (0)8 8313 0848

Fax

+61 (0)8 8313 7135

beverly.muhlhausler@adelaide.edu.au

Contact person for public queries

Name

Katie Wood

Address

Women's and Children's Hospital
72 King William Road, North Adelaide SA 5006 Australia
PO Box 11060, Adelaide SA 5001

Country

Australia

Phone

+61 (8)128 4436

Fax

Katie.Wood@sahmri.com

Contact person for scientific queries

Name

Beverly Muhlhausler

Address

FOODplus Research Centre
Waite Campus, The University of Adelaide
PMB 1, GLEN OSMOND, SA 5064

Country

Australia

Phone

+61 (0)8 8313 0848

Fax

+61 (0)8 8313 7135

beverly.muhlhausler@adelaide.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

Data considered commercial in confidence

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

No additional documents have been identified.

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