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
| Type | Name | Description |
|---|---|---|
| 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) |
| 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) |
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.