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Effect of Docosahexaenoic Acid (DHA)-Enriched Human Milk in Premature Newborns

NCT ID: NCT01062373

Last Updated: 2012-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-06-30

Brief Summary

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Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother. We hypothesized that the polyunsaturated fatty acid (PUFA) status of the premature newborn fed mother's milk is unbalanced because the content of DHA of the milk of mother nowadays is insufficient, whereas scientific arguments point-out the essential role of DHA and balanced AA/DHA ratio of human milk to explain the beneficial role of the breast-feeding at short, medium and long term. We will study the benefits of DHA supplements (TG-DHA versus GPL-DHA) of mothers in PUGA status improvement in their premature newborn consecutive to DHA enrichment and balanced AA/DHA ratio of human milk. GPL-DHA should be more effective than TG-DHA by protecting both n-3 and n-6 fatty acids pathways.

Detailed Description

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Conditions

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Premature

Keywords

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Premature Newborns Human Milk DHA Mother-child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TG-DHA

TG-DHA: lactating mothers and their newborn with mothers supplemented with Triglyceride enriched in docosahexaenoic acid

Group Type ACTIVE_COMPARATOR

Supplementation of lactating mothers who has delivered prematurely with DHA

Intervention Type DIETARY_SUPPLEMENT

Supplementation in DHA will be conducted for 1 month at the dose of 200 mg DHA per day provided by TG-DHA from Decola (products from Martek) (two soft capsules per day)

Control

Control: lactating mothers and their newborn with no supplementation given to the mother

Group Type NO_INTERVENTION

No interventions assigned to this group

GPL-DHA

GPL-DHA: lactating mothers and their newborn with mothers supplemented with Glycerophospholipid enriched in docosahexaenoic acid

Group Type EXPERIMENTAL

Supplementation of lactating mothers who has delivered prematurely with DHA

Intervention Type DIETARY_SUPPLEMENT

Supplementation in DHA will be conducted for 1 month at the dose of 200 mg DHA per day provided by GPL-DHA from ASL (10 g per day) (two soft capsules per day)

Interventions

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Supplementation of lactating mothers who has delivered prematurely with DHA

Supplementation in DHA will be conducted for 1 month at the dose of 200 mg DHA per day provided by TG-DHA from Decola (products from Martek) (two soft capsules per day)

Intervention Type DIETARY_SUPPLEMENT

Supplementation of lactating mothers who has delivered prematurely with DHA

Supplementation in DHA will be conducted for 1 month at the dose of 200 mg DHA per day provided by GPL-DHA from ASL (10 g per day) (two soft capsules per day)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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TG-DHA from Decola compagny in Belgium: oil of microalgae saled by Martek US compagny containing triglycerides enriched in DHA ; code 139 890 GPL-DHA from Application Santé des Lipides BioParc Vichy Hauterive France: dry yolk egg powder containing glycerophospholipids enriched in DHA code AA 22/12/11

Eligibility Criteria

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Inclusion Criteria

* Childbirth between 34 and 35 GA
* Breast-feeding
* Caucasian
* Affiliation to social security
* Obtained consent from mother, and parents for the child
* Mother with balanced diet
* No allergy to eggs
* Single pregnancy

Exclusion Criteria

* Allergy to egg
* Unbalanced diet
* Diabetes
* Known digestive disease
* Counter-indication with breast-feeding
* Cigarettes (more than 5 per day)
* Alcoholism (daily consumption of alcohol)
* Multiple pregnancy
Minimum Eligible Age

1 Day

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Véronique Millet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut National de la Santé Et de la Recherche Médicale, France

Locations

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Service de Médecine néonatale, Hôpital de la Conception

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2009-A00006-51

Identifier Type: REGISTRY

Identifier Source: secondary_id

C08-20

Identifier Type: -

Identifier Source: org_study_id