Plasma Profile of Exclusively Breastfed Infants
This study has been completed.
Information provided by (Responsible Party):
First received: August 16, 2012
Last updated: January 19, 2015
Last verified: January 2015
To characterize nutrient levels in breastfeeding infants and their mothers.
||Observational Model: Family-Based
Time Perspective: Prospective
||Plasma Profile of Exclusively Breastfed Infants
Primary Outcome Measures:
- Plasma carotenoids in breastfed infants [ Time Frame: At visit 1 (enrollment) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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 ]
Blood sample; Human Milk sample
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2012 (Final data collection date for primary outcome measure)
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
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Breastfeeding infants and their mothers
- 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.
- 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 ClinicalTrials.gov identifier: NCT01669655
|Fudan University of Shanghai
|Shanghai, Shanghai, China |
||Xianfeng Zhao, MD, PhD
||Abbott Nutrition, R&D China
No publications provided
ClinicalTrials.gov processed this record on March 31, 2015
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 16, 2012
||January 19, 2015
||China: Ethics Committee