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Plasma Profile of Exclusively Breastfed Infants

This study has been completed.
Information provided by (Responsible Party):
Abbott Nutrition Identifier:
First received: August 16, 2012
Last updated: January 19, 2015
Last verified: January 2015
To characterize nutrient levels in breastfeeding infants and their mothers.

Breast Fed Infants

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Plasma Profile of Exclusively Breastfed Infants

Resource links provided by NLM:

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Plasma carotenoids in breastfed infants [ Time Frame: At visit 1 (enrollment) ]

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

Enrollment: 56
Study Start Date: June 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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.

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

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.
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Please refer to this study by its identifier: NCT01669655

China, Shanghai
Fudan University of Shanghai
Shanghai, Shanghai, China
Sponsors and Collaborators
Abbott Nutrition
Study Chair: Xianfeng Zhao, MD, PhD Abbott Nutrition, R&D China
  More Information

Responsible Party: Abbott Nutrition Identifier: NCT01669655     History of Changes
Other Study ID Numbers: AK99
Study First Received: August 16, 2012
Last Updated: January 19, 2015 processed this record on April 27, 2017