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Krill Oil Supplementation: Effects on Breast Milk Composition

NCT03583502 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-07-11

No results posted yet for this study

Summary

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.

Conditions

  • Breast Milk Expression

Interventions

DIETARY_SUPPLEMENT

krill oil and fish oil supplement

Administration of 2 gelatin soft capsules per day of a combined krill and fish oil supplement, providing 250 mg/day of DHA and 70 mg/day of EPA, for overall 30 days.

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2017-07-31
Completion
2017-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03583502 on ClinicalTrials.gov