Plasma Profile of Exclusively Breastfed Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Abbott Nutrition.
Recruitment status was  Recruiting
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
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: 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 August 21, 2014