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
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Condition or disease |
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Breast Fed Infants |
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 |

- Plasma carotenoids in breastfed infants [ Time Frame: At visit 1 (enrollment) ]
- 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

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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 |
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.

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
China, Shanghai | |
Fudan University of Shanghai | |
Shanghai, Shanghai, China |
Study Chair: | Xianfeng Zhao, MD, PhD | Abbott Nutrition, R&D China |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |