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Plasma Profile of Exclusively Breastfed Infants

Plasma Profile of Exclusively Breastfed Infants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01669655
Enrollment
56
Registered
2012-08-21
Start date
2012-06-30
Completion date
2012-12-31
Last updated
2015-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Fed Infants

Brief summary

To characterize nutrient levels in breastfeeding infants and their mothers.

Detailed description

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.

Interventions

None listed

Sponsors

Abbott Nutrition
Lead SponsorINDUSTRY

Study design

Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Weeks to 16 Weeks
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Plasma carotenoids in breastfed infantsAt visit 1 (enrollment)

Secondary

MeasureTime frame
Plasma carotenoids in mothers of breastfed infantsAt visit 1 (enrollment)
Dietary carotenoid intake of mothers of breastfed infantsAt visit 1 (enrollment) and visit 2 (14 days)
Carotenoid levels in breastmilkAt visit 1 (enrollment) and visit 2 (14 days)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026