Impact of Nutrient Supplementation on Breast Milk Levels of Lactating Women
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Abbott Nutrition
- Enrollment
- 89
- Locations
- 6
- Primary Endpoint
- Breast milk concentration of carotenoids
Study Overview
Brief Summary
To investigate the impact of nutrient supplementation during lactation on levels in breast milk.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Control Supplement
soft-gel placebo capsules, 2 capsules from the placebo bottle per day
Intervention: Placebo (soybean oil and dl-alpha-tocopheryl acetate) (Dietary Supplement)
Experimental Supplement A
soft-gel capsules; 1 capsule from the experimental bottle and 1 capsule from the placebo bottle per day
Intervention: Similac Prenatal Vitamin soft-gel capsule (Dietary Supplement)
Experimental Supplement A
soft-gel capsules; 1 capsule from the experimental bottle and 1 capsule from the placebo bottle per day
Intervention: Placebo (soybean oil and dl-alpha-tocopheryl acetate) (Dietary Supplement)
Experimental Supplement B
soft-gel capsules; 2 capsules from the experimental bottle per day
Intervention: Similac Prenatal Vitamin soft-gel capsule (Dietary Supplement)
Outcomes
Primary Outcomes
Breast milk concentration of carotenoids
Time Frame: 1 - 43 days
Secondary Outcomes
- Breast milk concentration of fatty acids(1 - 43 days)