Breast Fed InfantsNCT01669655
Plasma Profile of Exclusively Breastfed Infants
An observational study of Breast Fed Infants, run by Abbott Nutrition at 1 site in China.
Trial summary
To characterize nutrient levels in breastfeeding infants and their mothers. Read more about this study
- Who is it for?
- Ages 6 to 16 weeksHealthy volunteers can take part
- Conditions the study is for
- Breast Fed Infants
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Breastfeeding infants and their mothers
Who may be able to join
- 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.
Show all 9Show fewer
- Mother is a non-smoker.
- Mother is in good health.
- Mother confirms her intention to continue breastfeeding.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To characterize nutrient levels in breastfeeding infants and their mothers.
Read the 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.
- Conditions
- Breast Fed Infants
- Medical subject headings
- Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma carotenoids in breastfed infants
Measured: At visit 1 (enrollment)
Secondary outcomes (3)
Plasma carotenoids in mothers of breastfed infants
Measured: At visit 1 (enrollment)
Dietary carotenoid intake of mothers of breastfed infants
Measured: At visit 1 (enrollment) and visit 2 (14 days)
Carotenoid levels in breastmilk
Measured: At visit 1 (enrollment) and visit 2 (14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Fed InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xianfeng Zhao, MD, PhD, Study chair, Abbott Nutrition, R&D China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669655
- Sponsor's protocol ID
- AK99
- Status last verified
- Jan 2015
- First submitted
- 16 Aug 2012
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Xu X, Zhao X, Berde Y, Low YL, Kuchan MJ. Milk and Plasma Lutein and Zeaxanthin Concentrations in Chinese Breast-Feeding Mother-Infant Dyads With Healthy Maternal Fruit and Vegetable Intake. J Am Coll Nutr. 2019 Feb;38(2):179-184. doi: 10.1080/07315724.2018.1490934. Epub 2018 Sep 11.
PubMed 30204542
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Profile of Exclusively Breastfed Infants
- ClinicalTrials.gov ID
- NCT01669655
- Acronym / sponsor ID
- AK99
- Conditions
- Breast Fed Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 16 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Breastfeeding infants and their mothers
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma carotenoids in breastfed infants
Time frame: At visit 1 (enrollment)
3 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
- Derived from this study: PubMed 30204542Xu X, Zhao X, Berde Y, Low YL, Kuchan MJ. Milk and Plasma Lutein and Zeaxanthin Concentrations in Chinese Breast-Feeding Mother-Infant Dyads With Healthy Maternal Fruit and Vegetable Intake. J Am Coll Nutr. 2019 Feb;38(2):179-184. doi: 10.1080/07315724.2018.1490934. Epub 2018 Sep 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianfeng Zhao, MD, PhD study chair
Abbott Nutrition, R&D China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Fed Infants, run by Abbott Nutrition at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma carotenoids in breastfed infants (time frame: At visit 1 (enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01669655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.