An interventional study of Supplementation of lactating mothers who has delivered prematurely with DHA and Supplementation of lactating mothers who has delivered prematurely with DHA in Premature, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Terminated at 1 site in France. Open to participants aged 1 Day to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-27.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Treatment
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 2 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 375 studies on the registry; 82 are open to participants now.
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Exclusion Criteria:
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
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
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)
Also known as: TG-DHA from Decola compagny in Belgium: oil of microalgae saled by Martek US compagny containing triglycerides enriched in DHA ; code 139 890
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)
Also known as: 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
To improve PUFA status in premature newborns
Time frame: 30 days
PUFA in human milk (HM) and mothers
Time frame: 6 months
Impact on HM bioactives
Time frame: 6 months
Change in inflammation and oxydative stress
Time frame: 6 months
Genes expression in newborns
Time frame: 6 months
Link between mothers genetics and HM DHA level
Time frame: 6 months
Newborn survey at 6 month-old
Time frame: 6 months
This study is terminated, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Institut National de la Santé Et de la Recherche Médicale, France