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

This study has been terminated.
(difficulties of recruitement)
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01062373
First received: February 3, 2010
Last updated: September 26, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improvement of Polyunsaturated Fatty Acids Status in Premature Newborns Following Docosahexaenoic Acid Enrichment of Human Milk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • To improve PUFA status in premature newborns [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PUFA in human milk (HM) and mothers [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Impact on HM bioactives [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Change in inflammation and oxydative stress [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Genes expression in newborns [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Link between mothers genetics and HM DHA level [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Newborn survey at 6 month-old [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: February 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TG-DHA
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
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)
Other Name: TG-DHA from Decola compagny in Belgium: oil of microalgae saled by Martek US compagny containing triglycerides enriched in DHA ; code 139 890
No Intervention: Control
Control: lactating mothers and their newborn with no supplementation given to the mother
Experimental: GPL-DHA
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
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)
Other Name: 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

Ages Eligible for Study:   up to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01062373

Locations
France
Service de Médecine néonatale, Hôpital de la Conception
Marseille Cedex 05, France, 13385
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Véronique Millet, MD, PhD Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01062373     History of Changes
Other Study ID Numbers: C08-20, 2009-A00006-51
Study First Received: February 3, 2010
Last Updated: September 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Premature Newborns
Human Milk
DHA
Mother-child

ClinicalTrials.gov processed this record on May 23, 2013