Lactation Fortification Study

Impact of Nutrient Supplementation on Breast Milk Levels of Lactating Women

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

Study Overview

• Status: Completed
• Conditions: Lactation
• Intervention / Treatment: Dietary supplement: Placebo (soybean oil and dl-alpha-tocopheryl acetate); Dietary supplement: Similac Prenatal Vitamin soft-gel capsule

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Northpoint Pediatrics, LLC
  • Ohio
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association, Inc
    • Kettering, Ohio, United States, 45420
      • Ohio Pediatric Research Association, Inc
    • Mayfield Heights, Ohio, United States, 44124
      • Institute of Clinical Research
    • Parma, Ohio, United States, 44129
      • The Cleveland Pediatric Research Center, LLC
    • Westlake, Ohio, United States, 44145
      • The Cleveland Pediatric Research Center, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood levels of nutrients and fatty acids	In mothers at 1 and 43 days In infants at 43 days	1 and 43 days

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Christina Sherry, PhD, RD, Abbott Nutrition

Publications and helpful links

General Publications

• Sherry CL, Oliver JS, Renzi LM, Marriage BJ. Lutein supplementation increases breast milk and plasma lutein concentrations in lactating women and infant plasma concentrations but does not affect other carotenoids. J Nutr. 2014 Aug;144(8):1256-63. doi: 10.3945/jn.114.192914. Epub 2014 Jun 4.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Estimate): May 31, 2013
• Last Update Submitted That Met QC Criteria: May 30, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Mother and Infant Pairs
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin E; Tocopherols; alpha-Tocopherol
• Other Study ID Numbers: AL05