NCT03583502

Krill Oil Supplementation: Effects on Breast Milk Composition

Completed NA Last updated 11 July 2018

What this trial tests

NA trial testing krill oil and fish oil supplement in Breast Milk Expression in 20 participants. Completed in 31 August 2017.

Timeline

1 June 2016

Primary endpoint
31 July 2017

31 August 2017

Quick facts

Lead sponsor	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	20
Start date	1 June 2016
Primary completion	31 July 2017
Estimated completion	31 August 2017
Sites	1 location across Italy

Drugs / interventions tested

• krill oil and fish oil supplement

Conditions studied

• Breast Milk Expression — all drugs for Breast Milk Expression →

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna — full company profile →

Who can join

18 and older, female only, with Breast Milk Expression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Docosahexaenoic acid (DHA) belongs to long-chain polyunsaturated fatty acids (LCPUFAs) category and is a major building block for neuronal and retinal membranes, playing a crucial role in brain and visual development within the first months of life. Due to the lack of enzymes for the synthesis of its precursors, neonates strictly rely on dietary intakes of DHA. Antarctic krill (Euphausia superba) is a small crustacean rich in phospholipid-bound DHA, which is highly bioavailable, but whether it is effective in increasing DHA excretion in breast milk (BM) has not been investigated yet.

This study aims to evaluate whether maternal supplementation with krill oil during breastfeeding increases DHA contents in breast milk BM.

Mothers of infants admitted to the Neonatal Intensive Care Unit will be enrolled in this open, randomized, controlled study and randomly allocated in 2 groups. Group 1 will receive an oral krill oil-based supplement providing 250 mg/day of DHA and 70 mg/day of EPA for 30 days, whereas group 2 serves as control. BM samples from both groups will be collected at baseline (T0) and day 30 (T1) and will undergo a qualitative analysis of LCPUFAs composition by gas chromatography/mass spectrometry.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Maternal Supplementation With Krill Oil During Breastfeeding and Long-Chain Polyunsaturated Fatty Acids (LCPUFAs) Composition of Human Milk: A Feasibility Study.
   Cimatti AG, Martini S, Munarini A, Zioutas M, et al · · 2018 · cited 6× · PMID 30622936 · DOI 10.3389/fped.2018.00407