Plasma Profile of Exclusively Breastfed Infants

This study is currently recruiting participants.
Verified August 2012 by Abbott Nutrition
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01669655
First received: August 16, 2012
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

To characterize nutrient levels in breastfeeding infants and their mothers.


Condition
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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma carotenoids in mothers of breastfed infants [ Time Frame: At visit 1 (enrollment) ] [ Designated as safety issue: No ]
  • Dietary carotenoid intake of mothers of breastfed infants [ Time Frame: At visit 1 (enrollment) and visit 2 (14 days) ] [ Designated as safety issue: No ]
  • Carotenoid levels in breastmilk [ Time Frame: At visit 1 (enrollment) and visit 2 (14 days) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood sample; human milk sample


Estimated Enrollment: 56
Study Start Date: July 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Weeks to 16 Weeks
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669655

Contacts
Contact: Kristen DeLuca, MS, RD, LD 614 624 5455 kristen.deluca@abbott.com

Locations
China
Fudan University of Shanghai Recruiting
Shanghai, China
Principal Investigator: Xu Xiu, MD         
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Nadim Rehman, MD Abbott Nutrition, Singapore
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01669655     History of Changes
Other Study ID Numbers: AK99
Study First Received: August 16, 2012
Last Updated: August 17, 2012
Health Authority: China: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014