HealthyNCT04655820
Maternal and Infant Health and Breast Milk Study in South China
An observational study of Healthy, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study was to investigate the nutrients in breast milk of Chinese mothers and its related factors, as well as exploring the early development of infants. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2018to 30 Dec 2022
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women and breast-feeding mothers of this study were recruited from Clifford Hospital during the perinatal period or lactation period
Who may be able to join
- age 20-45 years
- natural delivery, singleton pregnancy
- healthy term infants（at 37-42 weeks of pregnancy）
- don't smoke and drink
- self-evaluation as physical health
- breastfeeding at least until three months of age
- Apgar score > 8
- sign informed consent
Who cannot join
- suffering from mastitis
- gestational diabetes, hypertension and other metabolic diseases
- AIDS, tuberculosis and other acute or chronic infectious diseases
- severe heart and kidney diseases
- mental system diseases
- cancer and other malignant consumptive disease
Show all 10Show fewer
- take drugs that affect nutrient metabolism
- infants with congenital and genetic diseases
- with lactation contraindications
- don't agree to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to investigate the nutrients in breast milk of Chinese mothers and its related factors, as well as exploring the early development of infants.
Read the detailed description
Breast milk contains a variety of nutrients that are beneficial to the early development of infants, such as lipids, Vitamins and so on. At present, the level of these nutrients in milk and infant formula are lower and which are present in a different form from that in breast milk. Therefore, this study was designed to investigate the level of nutrients in breast milk of Chinese mothers and learn about its related factors, as well as exploring the relationships between these nutrients and the early development of infants.
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of nutrients in breast milk samples
The nutrients were detected from breast milk samples of mothers by chemical analysis
Measured: 14 months
The level of nutrients in blood samples
The nutrients were detected from blood samples of mothers and infants by chemical analysis
Measured: 14 months
Secondary outcomes (3)
General demographic materials
The general demographic materials of mothers were obtained by questionnaire or medical treatment records
Measured: 14 months
Dietary and lifestyle information
Dietary and lifestyle information of mothers were obtained by Food Frequency Questionnaire and 24-hour meal review questionnaire
Measured: 14 months
Health follow-up
Dietary and health outcome of infants were obtained by questionnaire or medical treatment records
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start20 Nov 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huilian Zhu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655820
- Sponsor's protocol ID
- HM-2020
- Status last verified
- Mar 2025
- First submitted
- 1 Nov 2020
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Infant Health and Breast Milk Study in South China
- ClinicalTrials.gov ID
- NCT04655820
- Acronym / sponsor ID
- HM-2020
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 7 Dec 2020 (actual)
- 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.
The purpose of this study was to investigate the nutrients in breast milk of Chinese mothers and its related factors, as well as exploring the early development of infants.
Detailed description
Breast milk contains a variety of nutrients that are beneficial to the early development of infants, such as lipids, Vitamins and so on. At present, the level of these nutrients in milk and infant formula are lower and which are present in a different form from that in breast milk. Therefore, this study was designed to investigate the level of nutrients in breast milk of Chinese mothers and learn about its related factors, as well as exploring the relationships between these nutrients and the early development of infants.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women and breast-feeding mothers of this study were recruited from Clifford Hospital during the perinatal period or lactation period
Key inclusion criteria (8 listed)
- age 20-45 years
- natural delivery, singleton pregnancy
- healthy term infants（at 37-42 weeks of pregnancy）
- don't smoke and drink
- self-evaluation as physical health
Key exclusion criteria (10 listed)
- suffering from mastitis
- gestational diabetes, hypertension and other metabolic diseases
- AIDS, tuberculosis and other acute or chronic infectious diseases
- severe heart and kidney diseases
- mental system diseases
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
The level of nutrients in breast milk samples
Time frame: 14 months
The nutrients were detected from breast milk samples of mothers by chemical analysis
The level of nutrients in blood samples
Time frame: 14 months
The nutrients were detected from blood samples of mothers and infants by chemical analysis
3 secondary outcomes
General demographic materials
Time frame: 14 months
Dietary and lifestyle information
Time frame: 14 months
Health follow-up
Time frame: 14 months
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 6 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy, run by Sun Yat-sen University 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 8 inclusion and 10 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 6 Mar 2025. 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?
The level of nutrients in breast milk samples (time frame: 14 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2025.