Lactation Fortification Study

Phase 3

Completed

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

• Registration Number: NCT01747668
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-12
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-30
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Supplement	Placebo (soybean oil and dl-alpha-tocopheryl acetate)	soft-gel placebo capsules, 2 capsules from the placebo bottle per day
Experimental Supplement A	Similac Prenatal Vitamin soft-gel capsule	soft-gel capsules; 1 capsule from the experimental bottle and 1 capsule from the placebo bottle per day
Experimental Supplement A	Placebo (soybean oil and dl-alpha-tocopheryl acetate)	soft-gel capsules; 1 capsule from the experimental bottle and 1 capsule from the placebo bottle per day
Experimental Supplement B	Similac Prenatal Vitamin soft-gel capsule	soft-gel capsules; 2 capsules from the experimental bottle per day

Primary Outcome Measures

Name	Time	Method
Breast milk concentration of carotenoids	1 - 43 days

Secondary Outcome Measures

Name	Time	Method
Breast milk concentration of fatty acids	1 - 43 days

Trial Locations

Locations (4)

Ohio Pediatric Research Association, Inc; 🇺🇸 Kettering, Ohio, United States

The Cleveland Pediatric Research Center, LLC; 🇺🇸 Westlake, Ohio, United States

Institute of Clinical Research; 🇺🇸 Mayfield Heights, Ohio, United States

Northpoint Pediatrics, LLC; 🇺🇸 Indianapolis, Indiana, United States