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Lactation Fortification Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01747668
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):

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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Nutrient Supplementation on Breast Milk Levels of Lactating Women
Study Start Date : November 2012
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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: 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


Outcome Measures

Primary Outcome Measures :
  1. Breast milk concentration of carotenoids [ Time Frame: 1 - 43 days ]

Secondary Outcome Measures :
  1. Breast milk concentration of fatty acids [ Time Frame: 1 - 43 days ]

Other Outcome Measures:
  1. Blood levels of nutrients and fatty acids [ Time Frame: 1 and 43 days ]
    In mothers at 1 and 43 days In infants at 43 days


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01747668     History of Changes
Other Study ID Numbers: AL05
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013

Keywords provided by Abbott Nutrition:
Mother and Infant Pairs

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