NCT03583502

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

June 27, 2018

Last Update Submit

July 10, 2018

Conditions

Breast Milk Expression

Keywords

LCPUFADHAkrill oilsupplementationbreast milk

Outcome Measures

Primary Outcomes (2)

  • Breast milk excretion of docosahexaenoic acid (DHA)

    Qualitative analysis of DHA concentration in breast milk

    Baseline (T0)

  • Breast milk excretion of docosahexaenoic acid (DHA)

    Qualitative analysis of DHA concentration in breast milk

    After 30 days of supplementation (T1)

Secondary Outcomes (4)

  • Breast milk excretion of eicosapentaenoic acid (EPA)

    Baseline (T0)

  • Breast milk excretion of eicosapentaenoic acid (EPA)

    After 30 days of supplementation (T1)

  • Breast milk excretion of arachidonic acid (AA)

    Baseline (T0)

  • Breast milk excretion of arachidonic acid (AA)

    After 30 days of supplementation (T1)

Study Arms (2)

Supplemented

EXPERIMENTAL

krill oil and fish oil supplement

Dietary Supplement: krill oil and fish oil supplement

Controls

NO INTERVENTION

The control group did not receive any supplementation.

Interventions

krill oil and fish oil supplementDIETARY_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.

Supplemented

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- ongoing breastfeeding

You may not qualify if:

  • \- ongoing LCPUFA supplementation at the time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital

Bologna, 40138, Italy

Location

Related Publications (1)

  • Cimatti AG, Martini S, Munarini A, Zioutas M, Vitali F, Aceti A, Mantovani V, Faldella G, Corvaglia L. Maternal Supplementation With Krill Oil During Breastfeeding and Long-Chain Polyunsaturated Fatty Acids (LCPUFAs) Composition of Human Milk: A Feasibility Study. Front Pediatr. 2018 Dec 20;6:407. doi: 10.3389/fped.2018.00407. eCollection 2018.

    PMID: 30622936DERIVED

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast FeedingFeeding BehaviorBehavior

Study Officials

  • Luigi Corvaglia, Prof

    luigi.corvaglia@unibo.it

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 27, 2018

First Posted

July 11, 2018

Study Start

June 1, 2016

Primary Completion

July 31, 2017

Study Completion

August 31, 2017

Last Updated

July 11, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)