Plasma Profile of Exclusively Breastfed Infants
This study is currently recruiting participants.
Verified August 2012 by Abbott Nutrition
Sponsor:
Abbott Nutrition
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
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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 May 22, 2013