Lactation Fortification Study
Completed · Phase 3 · Has a placebo group
Conditions studied: Lactation
In brief
To investigate the impact of nutrient supplementation during lactation on levels in breast milk.
Key facts
- Study ID
- NCT01747668
- Run by
- Abbott Nutrition
- People needed
- 89
- Starts
- 2012-11-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2013-05-31
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Subjects will be eligible for the study if they meet all of the following inclusion criteria:
- Mother with singleton birth, 37-42 weeks gestation and ≥ 2490g
- Pre-pregnancy BMI </= 30
- Mother is ≥ 18 years of age
- Mother is 4-6 weeks postpartum and has been successfully continuously lactating
- Mother agrees to abstain from the use of any Docosahexaenoic acid (DHA), lutein and/or vitamin E containing supplements for at least 10 days prior to providing a baseline breast milk sample
- Mother agrees to abstain from the use of non-study supplements throughout the study
- Mother plans to continue breastfeeding for at least 6 weeks from the start of the study
- No significant ongoing medical problems in the infant as determined from infant's medical history as related by the parent(s) to the enrolling center personnel
You may not qualify if…
- Subjects will be excluded from the study if they meet any of the following criteria:
- Subject had adverse maternal and/or fetal medical history
- Subject is participating in a non-Abbott approved concomitant trial
- Mother is taking cholesterol medication and/or medication affecting lipid absorption and/or transport
Where it is running
- Northpoint Pediatrics, LLC — Indianapolis, Indiana, United States
- Ohio Pediatric Research Association, Inc — Dayton, Ohio, United States
- Ohio Pediatric Research Association, Inc — Kettering, Ohio, United States
- Institute of Clinical Research — Mayfield Heights, Ohio, United States
- The Cleveland Pediatric Research Center, LLC — Parma, Ohio, United States
- The Cleveland Pediatric Research Center, LLC — Westlake, Ohio, United States
Full record on ClinicalTrials.gov
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