Lactation Fortification Study

Abbott

Status and phase: Completed; Phase 3

Conditions: Lactation

Treatments: Dietary Supplement: Similac Prenatal Vitamin soft-gel capsule; Dietary Supplement: Placebo (soybean oil and dl-alpha-tocopheryl acetate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01747668

AL05

Details and patient eligibility

About

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

Enrollment: 89 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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89 participants in 3 patient groups, including a placebo group

Control Supplement

Placebo Comparator group

Description:

soft-gel placebo capsules, 2 capsules from the placebo bottle per day

Treatment:

Dietary Supplement: Placebo (soybean oil and dl-alpha-tocopheryl acetate)

Experimental Supplement A

Experimental group

Description:

soft-gel capsules; 1 capsule from the experimental bottle and 1 capsule from the placebo bottle per day

Treatment:

Dietary Supplement: Placebo (soybean oil and dl-alpha-tocopheryl acetate)

Dietary Supplement: Similac Prenatal Vitamin soft-gel capsule

Experimental Supplement B

Experimental group

Description:

soft-gel capsules; 2 capsules from the experimental bottle per day

Treatment:

Dietary Supplement: Similac Prenatal Vitamin soft-gel capsule