Lactation Fortification Study

Study Overview
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Brief Summary
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To investigate the impact of nutrient supplementation during lactation on levels in breast milk.

Official Title
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Impact of Nutrient Supplementation on Breast Milk Levels of Lactating Women

Conditions
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Lactation

Intervention / Treatment
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* Dietary Supplement: Similac Prenatal Vitamin soft-gel capsule
* Dietary Supplement: Placebo (soybean oil and dl-alpha-tocopheryl acetate)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Supplement<br>soft-gel placebo capsules, 2 capsules from the placebo bottle per day | Dietary Supplement: Placebo (soybean oil and dl-alpha-tocopheryl acetate)<br>* Two capsules per day for the Placebo Group; One capsule per day for the Experimental Group A<br>|
| Experimental: Experimental Supplement A<br>soft-gel capsules; 1 capsule from the experimental bottle and 1 capsule from the placebo bottle per day | Dietary Supplement: Similac Prenatal Vitamin soft-gel capsule<br>* One capsule per day for Experimental Supplement A Group; Two capsules per day for Experimental Supplement B Group<br>Dietary Supplement: Placebo (soybean oil and dl-alpha-tocopheryl acetate)<br>* Two capsules per day for the Placebo Group; One capsule per day for the Experimental Group A<br>|
| Experimental: Experimental Supplement B<br>soft-gel capsules; 2 capsules from the experimental bottle per day | Dietary Supplement: Similac Prenatal Vitamin soft-gel capsule<br>* One capsule per day for Experimental Supplement A Group; Two capsules per day for Experimental Supplement B Group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast milk concentration of carotenoids |  | 1 - 43 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast milk concentration of fatty acids |  | 1 - 43 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mother and Infant Pairs