Clinical Trials Directory

Trials / Terminated

TerminatedNCT01062373

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

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
2 (actual)
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France · Other Government
Sex
All
Age
1 Day – 40 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTSupplementation of lactating mothers who has delivered prematurely with DHASupplementation 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)
DIETARY_SUPPLEMENTSupplementation of lactating mothers who has delivered prematurely with DHASupplementation 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)

Timeline

Start date
2010-02-01
Primary completion
2012-06-01
Completion
2012-06-01
First posted
2010-02-04
Last updated
2012-09-27

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01062373. Inclusion in this directory is not an endorsement.