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

Primary Purpose

Premature

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Supplementation of lactating mothers who has delivered prematurely with DHA
Supplementation of lactating mothers who has delivered prematurely with DHA
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature focused on measuring Premature Newborns, Human Milk, DHA, Mother-child

Eligibility Criteria

1 Day - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Service de Médecine néonatale, Hôpital de la Conception

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Experimental

Arm Label

TG-DHA

Control

GPL-DHA

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

To improve PUFA status in premature newborns

Secondary Outcome Measures

PUFA in human milk (HM) and mothers
Impact on HM bioactives
Change in inflammation and oxydative stress
Genes expression in newborns
Link between mothers genetics and HM DHA level
Newborn survey at 6 month-old

Full Information

First Posted
February 3, 2010
Last Updated
September 26, 2012
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01062373
Brief Title
Effect of Docosahexaenoic Acid (DHA)-Enriched Human Milk in Premature Newborns
Acronym
DHARMA
Official Title
Improvement of Polyunsaturated Fatty Acids Status in Premature Newborns Following Docosahexaenoic Acid Enrichment of Human Milk
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
difficulties of recruitement
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature
Keywords
Premature Newborns, Human Milk, DHA, Mother-child

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TG-DHA
Arm Type
Active Comparator
Arm Description
TG-DHA: lactating mothers and their newborn with mothers supplemented with Triglyceride enriched in docosahexaenoic acid
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control: lactating mothers and their newborn with no supplementation given to the mother
Arm Title
GPL-DHA
Arm Type
Experimental
Arm Description
GPL-DHA: lactating mothers and their newborn with mothers supplemented with Glycerophospholipid enriched in docosahexaenoic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
Supplementation of lactating mothers who has delivered prematurely with DHA
Other Intervention Name(s)
TG-DHA from Decola compagny in Belgium: oil of microalgae saled by Martek US compagny containing triglycerides enriched in DHA ; code 139 890
Intervention Description
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
Intervention Name(s)
Supplementation of lactating mothers who has delivered prematurely with DHA
Other Intervention Name(s)
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
Intervention Description
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)
Primary Outcome Measure Information:
Title
To improve PUFA status in premature newborns
Time Frame
30 days
Secondary Outcome Measure Information:
Title
PUFA in human milk (HM) and mothers
Time Frame
6 months
Title
Impact on HM bioactives
Time Frame
6 months
Title
Change in inflammation and oxydative stress
Time Frame
6 months
Title
Genes expression in newborns
Time Frame
6 months
Title
Link between mothers genetics and HM DHA level
Time Frame
6 months
Title
Newborn survey at 6 month-old
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique Millet, MD, PhD
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Médecine néonatale, Hôpital de la Conception
City
Marseille Cedex 05
ZIP/Postal Code
13385
Country
France

12. IPD Sharing Statement

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

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