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

Improvement of Polyunsaturated Fatty Acids Status in Premature Newborns Following Docosahexaenoic Acid Enrichment of Human Milk

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.

Study Overview

• Status: Terminated
• Conditions: Premature
• Intervention / Treatment: Dietary supplement: Supplementation of lactating mothers who has delivered prematurely with DHA; Dietary supplement: Supplementation of lactating mothers who has delivered prematurely with DHA

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille Cedex 05, France, 13385
    • Service de Médecine néonatale, Hôpital de la Conception

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: TG-DHA from Decola compagny in Belgium: oil of microalgae saled by Martek US compagny containing triglycerides enriched in DHA ; code 139 890; 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 Names: 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
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 TG-DHA from Decola (products from Martek) (two soft capsules per day); Other Names: TG-DHA from Decola compagny in Belgium: oil of microalgae saled by Martek US compagny containing triglycerides enriched in DHA ; code 139 890; 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To improve PUFA status in premature newborns	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Newborn survey at 6 month-old	6 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: February 3, 2010
• First Submitted That Met QC Criteria: February 3, 2010
• First Posted (Estimate): February 4, 2010

Study Record Updates

• Last Update Posted (Estimate): September 27, 2012
• Last Update Submitted That Met QC Criteria: September 26, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: DHA; Human Milk; Premature Newborns; Mother-child
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: C08-20; 2009-A00006-51 (Registry Identifier: IDRCB)