Trial Review

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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
Date results information 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] 292472 0
None
Universal Trial Number (UTN)
U1111-1199-5378
Trial acronym
None
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
maternal and infant health 304093 0
Condition category
Condition code
Diet and Nutrition 303429 303429 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 303989 303989 0 0
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] 299056 0
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] 303293 0
Breast milk omega-3 fatty acid concentrations
Timepoint [1] 303293 0
4 weeks after commencement of capsules (study end-point)
Secondary outcome [1] 338544 0
Blood omega-3 fatty acids concentrations at the end of the intervention
Timepoint [1] 338544 0
4 weeks after commencement of capsules (study end-point)
Secondary outcome [2] 338545 0
Breast-milk omega-3 concentrations across the 4 week study period
Timepoint [2] 338545 0
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
NA
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
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 8961 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 17333 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 297039 0
Commercial sector/Industry
Name [1] 297039 0
Pronova BioPharma
Country [1] 297039 0
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] 296047 0
University
Name [1] 296047 0
The University of Adelaide
Address [1] 296047 0
Floor/Room 4
Rundle Mall Plaza
North Terrace
Adelaide
SA 5005
Country [1] 296047 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298223 0
Women's and Children's Health Network HREC
Ethics committee address [1] 298223 0
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] 298223 0
Australia
Date submitted for ethics approval [1] 298223 0
08/03/2017
Approval date [1] 298223 0
08/08/2017
Ethics approval number [1] 298223 0
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 76394 0
A/Prof Beverly Muhlhausler
Address 76394 0
FOODplus Research Centre
Waite Campus, The University of Adelaide
PMB 1, GLEN OSMOND, SA 5064
Country 76394 0
Australia
Phone 76394 0
+61 (0)8 8313 0848
Fax 76394 0
+61 (0)8 8313 7135
Email 76394 0
beverly.muhlhausler@adelaide.edu.au
Contact person for public queries
Name 76395 0
Dr Katie Wood
Address 76395 0
Women's and Children's Hospital
72 King William Road, North Adelaide SA 5006 Australia
PO Box 11060, Adelaide SA 5001
Country 76395 0
Australia
Phone 76395 0
+61 (8)128 4436
Fax 76395 0
Email 76395 0
Katie.Wood@sahmri.com
Contact person for scientific queries
Name 76396 0
A/Prof Beverly Muhlhausler
Address 76396 0
FOODplus Research Centre
Waite Campus, The University of Adelaide
PMB 1, GLEN OSMOND, SA 5064
Country 76396 0
Australia
Phone 76396 0
+61 (0)8 8313 0848
Fax 76396 0
+61 (0)8 8313 7135
Email 76396 0
beverly.muhlhausler@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.