Effect of n-3 Polyunsaturated Fatty Acids Supplementation on Human Milk Composition of Lactating … (NCT01288313) | Clinical Trial Compass
CompletedNot Applicable
Effect of n-3 Polyunsaturated Fatty Acids Supplementation on Human Milk Composition of Lactating Women
France82 participantsStarted 2011-09
Plain-language summary
We propose to measure the LCPUFA human milk (linolenic acid, linoleic acid, docosahexaenoic acid, arachidonic acid) according to fatty acids nature and quantities consumed by lactating women
Who can participate
Age range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Lactating women more than 1 month and less than 4 month with neonate whom term is between 37 and 42 gestational age
* Women who agree to consume fatty fish two times per week
* Free consent
Exclusion Criteria:
* Women with multiple infants
* Chronic treatments more than 8 days
* Women with treatment during supplementation period
* Women with maternal pathology not compatible with breastfeed
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focused on measuring changes in alpha-linolenic acid (18:3 n-3) in breast milk between day 15 and day 30 of supplementation — can you help me understand what those results might mean for the nutritional quality of my breast milk and my baby's development?
2Since this study is completed, has the data been published anywhere, and would you be able to review the findings with me to see if omega-3 supplementation during breastfeeding is something worth considering in my situation?
3The trial specifically involved lactating women taking n-3 polyunsaturated fatty acid supplements — are there any safety considerations I should know about before taking omega-3 supplements while breastfeeding, such as dosage limits or potential interactions?
4Given that this was a relatively short study measuring outcomes at just 15 and 30 days, do we know enough about longer-term effects of omega-3 supplementation on breast milk composition to make an informed decision together?
5Are there standard dietary recommendations or food-based ways to increase omega-3 levels in my breast milk that my care team would suggest I consider before or instead of a supplement regimen like the one studied in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15