NCT01062373

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 27, 2012

Status Verified

January 1, 2012

Enrollment Period

2.3 years

First QC Date

February 3, 2010

Last Update Submit

September 26, 2012

Conditions

Premature

Keywords

Premature NewbornsHuman MilkDHAMother-child

Outcome Measures

Primary Outcomes (1)

  • To improve PUFA status in premature newborns

    30 days

Secondary Outcomes (6)

  • PUFA in human milk (HM) and mothers

    6 months

  • Impact on HM bioactives

    6 months

  • Change in inflammation and oxydative stress

    6 months

  • Genes expression in newborns

    6 months

  • Link between mothers genetics and HM DHA level

    6 months

  • +1 more secondary outcomes

Study Arms (3)

TG-DHA

ACTIVE COMPARATOR

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

Dietary Supplement: Supplementation of lactating mothers who has delivered prematurely with DHA

Control

NO INTERVENTION

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

GPL-DHA

EXPERIMENTAL

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

Dietary Supplement: Supplementation of lactating mothers who has delivered prematurely with DHA

Interventions

Supplementation of lactating mothers who has delivered prematurely with DHADIETARY_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)

Also known as: TG-DHA from Decola compagny in Belgium: oil of microalgae saled by Martek US compagny containing triglycerides enriched in DHA ; code 139 890
TG-DHA

Eligibility Criteria

Age1 Day - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Médecine néonatale, Hôpital de la Conception

Marseille, 13385, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Véronique Millet, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 4, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 27, 2012

Record last verified: 2012-01

Locations

FR(1)