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Plasma Profile of Exclusively Breastfed Infants

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ClinicalTrials.gov Identifier: NCT01669655
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Study Description
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Brief Summary:
To characterize nutrient levels in breastfeeding infants and their mothers.

Condition or disease
Breast Fed Infants

Detailed Description:
The objectives of this study are (1) to characterize plasma lutein levels in breastfed infants in an Asian population where lactating mothers have diets habitually high in lutein and (2) investigate how blood lutein levels in breastfed infants vary according to lutein content of the mothers' milk in such a population.

Study Design
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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Plasma Profile of Exclusively Breastfed Infants
Study Start Date : June 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Plasma carotenoids in breastfed infants [ Time Frame: At visit 1 (enrollment) ]

Secondary Outcome Measures :
  1. Plasma carotenoids in mothers of breastfed infants [ Time Frame: At visit 1 (enrollment) ]
  2. Dietary carotenoid intake of mothers of breastfed infants [ Time Frame: At visit 1 (enrollment) and visit 2 (14 days) ]
  3. Carotenoid levels in breastmilk [ Time Frame: At visit 1 (enrollment) and visit 2 (14 days) ]

Biospecimen Retention:   Samples With DNA
Blood sample; Human Milk sample

Eligibility Criteria
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Ages Eligible for Study:   6 Weeks to 16 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Breastfeeding infants and their mothers
Criteria

Inclusion Criteria:

  • Infant is judged to be in good health.
  • Infant is a singleton from a full term birth.
  • Infant's birth weight was > 2490 g.
  • Infant is between 6 weeks and 16 weeks (42 to 112 days).
  • Infant must have been exclusively breastfed at enrollment.
  • Mother's intake indicates a consumption of an average of at least three servings of fruit and/or vegetables per day.
  • Mother is a non-smoker.
  • Mother is in good health.
  • Mother confirms her intention to continue breastfeeding.

Exclusion Criteria:

  • An adverse maternal, fetal or infant medical history that is thought to have potential for effects on growth, and/or development.
  • Infants who have consumed medications or herbal preparations during past 14 days prior to enrollment.
  • Infants who have consumed any solid or liquid foods or juices prior to enrollment.
  • Infants who have received any supplements containing carotenoids prior to enrollment.
  • Mother who is consuming dietary supplements containing carotenoids.
  • Participation in another study that has not been approved as a concomitant study.
Contacts and Locations
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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): NCT01669655


Locations
China, Shanghai
Fudan University of Shanghai
Shanghai, Shanghai, China
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Xianfeng Zhao, MD, PhD Abbott Nutrition, R&D China
More Information
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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01669655     History of Changes
Other Study ID Numbers: AK99
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015