Lactation
Conditions
Keywords
Mother and Infant Pairs
Brief summary
To investigate the impact of nutrient supplementation during lactation on levels in breast milk.
Interventions
DIETARY_SUPPLEMENTSimilac Prenatal Vitamin soft-gel capsule
One capsule per day for Experimental Supplement A Group; Two capsules per day for Experimental Supplement B Group
DIETARY_SUPPLEMENTPlacebo (soybean oil and dl-alpha-tocopheryl acetate)
Two capsules per day for the Placebo Group; One capsule per day for the Experimental Group A
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects will be eligible for the study if they meet all of the following inclusion criteria: 1. Mother with singleton birth, 37-42 weeks gestation and ≥ 2490g 2. Pre-pregnancy BMI \</= 30 3. Mother is ≥ 18 years of age 4. Mother is 4-6 weeks postpartum and has been successfully continuously lactating 5. 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 6. Mother agrees to abstain from the use of non-study supplements throughout the study 7. Mother plans to continue breastfeeding for at least 6 weeks from the start of the study 8. 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: 1. Subject had adverse maternal and/or fetal medical history 2. Subject is participating in a non-Abbott approved concomitant trial 3. Mother is taking cholesterol medication and/or medication affecting lipid absorption and/or transport
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breast milk concentration of carotenoids | 1 - 43 days |
Secondary
| Measure | Time frame |
|---|---|
| Breast milk concentration of fatty acids | 1 - 43 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood levels of nutrients and fatty acids | 1 and 43 days | In mothers at 1 and 43 days In infants at 43 days |
Countries
United States
Outcome results
None listed