Impact of Nutrient Supplementation on Breast Milk Levels of Lactating Women

Abbott Nutrition4 sites in 1 country89 target enrollmentNovember 2012

ConditionsLactation

Overview

To investigate the impact of nutrient supplementation during lactation on levels in breast milk.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Sponsor

Responsible Party

Sponsor

•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

•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