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

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

Status: Terminated

Conditions: Premature

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01062373

C08-20

2009-A00006-51 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 1 day to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2 participants in 3 patient groups

TG-DHA

Active Comparator group

Description:

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

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

Control

No Intervention group

Description:

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

GPL-DHA

Experimental group

Description:

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

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