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OpenTrials
Completed

NCT Number: NCT01669655

Plasma Profile of Exclusively Breastfed Infants

To characterize nutrient levels in breastfeeding infants and their mothers.

Completed

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Key information

Age range

6 week–16 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University of Shanghai

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Plasma carotenoids in breastfed infants

    Time frame: At visit 1 (enrollment)

Secondary outcomes

  1. Plasma carotenoids in mothers of breastfed infants

    Time frame: At visit 1 (enrollment)

  2. Dietary carotenoid intake of mothers of breastfed infants

    Time frame: At visit 1 (enrollment) and visit 2 (14 days)

  3. Carotenoid levels in breastmilk

    Time frame: At visit 1 (enrollment) and visit 2 (14 days)

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 21, 2012
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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