Lactation Fortification Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01747668
First received: December 10, 2012
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Lactation
Dietary Supplement: Similac Prenatal Vitamin soft-gel capsule
Dietary Supplement: Placebo (soybean oil and dl-alpha-tocopheryl acetate)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Nutrient Supplementation on Breast Milk Levels of Lactating Women

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Breast milk concentration of carotenoids [ Time Frame: 1 - 43 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Breast milk concentration of fatty acids [ Time Frame: 1 - 43 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Blood levels of nutrients and fatty acids [ Time Frame: 1 and 43 days ] [ Designated as safety issue: No ]
    In mothers at 1 and 43 days In infants at 43 days


Enrollment: 89
Study Start Date: November 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Similac Prenatal Vitamin soft-gel capsule
One capsule per day for Experimental Supplement A Group; Two capsules per day for Experimental Supplement B Group
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 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747668

Locations
United States, Indiana
Northpoint Pediatrics, LLC
Indianapolis, Indiana, United States, 46256
United States, Ohio
Ohio Pediatric Research Association, Inc
Dayton, Ohio, United States, 45414
Ohio Pediatric Research Association, Inc
Kettering, Ohio, United States, 45420
Institute of Clinical Research
Mayfield Heights, Ohio, United States, 44124
The Cleveland Pediatric Research Center, LLC
Parma, Ohio, United States, 44129
The Cleveland Pediatric Research Center, LLC
Westlake, Ohio, United States, 44145
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Christina Sherry, PhD, RD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01747668     History of Changes
Other Study ID Numbers: AL05
Study First Received: December 10, 2012
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Nutrition:
Mother and Infant Pairs

Additional relevant MeSH terms:
Vitamin E
Alpha-Tocopherol
Tocopherols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014