Breast Milk CollectionNCT04102085
the Study of Persistent Organic Pollutants in Human Milk
An observational study of Breast Milk Collection, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The study aims to recruit eligible participants and conduct interviews, collect human milk samples, and conduct laboratory analysis of persistent organic pollutants' levels in human milk samples. Read more about this study
- Who is it for?
- Ages Up to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Collection
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Sep 2019to 25 May 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 Up to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Fifty eligible participants (nursing mothers) will be identified during their postnatal visits at four selected Maternal Child Health Centres (MCHCs) of the Department of Health, representing four major regions in Hong Kong: Sai Ying Pun MCHC (Hong Kong Island); Kowloon City MCHC (Kowloon); Madam Yung Fung Shee MCHC (New Territories West); and Ma On Shan MCHC (New Territories East). If the recruitment is unsatisfactory in the above four centres, other MCHCs will be involved.
Who may be able to join
- Primiparae;
- 30 years of age or below;
- Have normal pregnancy;
- Breastfeeding one infant only, and not multiple pregnancy;
- Resided in Hong Kong for at least 10 years immediately before the date of interview;
- Available for sample collection within 3 to 8 weeks of delivery; and
- Both mother and child should be apparently healthy and free from any known infectious or other diseases (e.g. clinical hepatitis, AIDs, HIV).
Who cannot join
- participants with previously diagnosed major diseases such as hepatitis, AIDS and other such diseases shall be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to recruit eligible participants and conduct interviews, collect human milk samples, and conduct laboratory analysis of persistent organic pollutants' levels in human milk samples.
Read the detailed description
Persistent Organic Pollutants (POPs) are a group of chemicals which have been intentionally or inadvertently produced and introduced into the environment. Due to their stability and transport properties, they are widely distributed around the world, and are even found in places where they had never been used, such as the arctic regions. Given their long half-lives and fat solubility, POPs tend to bioaccumulate in animals, particularly in long-lived species at the top of the food-chain. POPs appear at higher concentrations in fat-containing foods, including fish, meat, eggs and milk. POPs are also present in the human body and traces can be found in human milk. The most commonly mentioned POPs are organochlorine pesticides, such as DDT, industrial chemicals, most notably polychlorinated biphenyls (PCBs), and by-products, especially polychlorinated dibenzodioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs). As a group, POPs are of concern for both the environment and human health 1.
With the ratification of the Stockholm Convention on POPs in early 2004, the international community signaled its commitment to reduce or eliminate production and emission of POPs into the environment and ultimately, the human body. There were 12 POPs initially listed under the Convention in 2004 2. The Convention is effective to the People's Republic of China, including the Hong Kong Special Administrative Region (HKSAR). The Environmental Protection Department (EPD) coordinates the HKSAR Government's efforts for the Convention and prepared the HKSAR Implementation Plan 3, in which the Department of Health (DH) is required to conduct the regular local monitoring of POPs in human milk.
The first study of POPs in human milk by DH was conducted during 2008 to 2011, which was made reference to Guidelines for Developing a National Protocol of the Fourth World Health Organization (WHO) - Coordinated Survey of Human Milk for POPs in Cooperation with United Nations Environment Programme (UN Environment) (2007) 4.
Results of the first study by DH was published in a scientific journal 5 and submitted to EPD, which were also discussed in the HKSAR Implementation Plan for the Stockholm Convention on POPs (2016) 5. Compared to the related earlier local studies 7,8,9 conducted by local universities, levels of POPs in human milk had declined over time.
Mothers should be reassured that breast milk is naturally the superior food for infants. The study is intended to provide data to evaluate the effectiveness of the international agreement, i.e. the Stockholm Convention, which aims to reduce the levels of certain POPs in our environment.
The study will also support national capabilities for monitoring and sound management of POPs.
- Conditions
- Breast Milk Collection
- Being tested
- no intervention
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Mothers under 30 | no intervention will be administered Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of persistent organic pollutants in breast milk
Approximately 30 types of persistent organic pollutants will be tested
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start25 Sep 2019
- Primary completion25 Sep 2021
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Milk CollectionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tse Lap Ah, Chinese University of Hong Kong
- Investigators
- Lap Ah Tse, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102085
- Sponsor's protocol ID
- DH/SEB/NCD/18/2018-19
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2019
- Last updated
- 23 Oct 2026
- Results posted
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Study of Persistent Organic Pollutants in Human Milk
- ClinicalTrials.gov ID
- NCT04102085
- Acronym / sponsor ID
- DH/SEB/NCD/18/2018-19
- Conditions
- Breast Milk Collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 25 Sep 2021 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 25 Sep 2019 (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 study aims to recruit eligible participants and conduct interviews, collect human milk samples, and conduct laboratory analysis of persistent organic pollutants' levels in human milk samples.
Detailed description
Persistent Organic Pollutants (POPs) are a group of chemicals which have been intentionally or inadvertently produced and introduced into the environment. Due to their stability and transport properties, they are widely distributed around the world, and are even found in places where they had never been used, such as the arctic regions. Given their long half-lives and fat solubility, POPs tend to bioaccumulate in animals, particularly in long-lived species at the top of the food-chain. POPs appear at higher concentrations in fat-containing foods, including fish, meat, eggs and milk. POPs are also present in the human body and traces can be found in human milk. The most commonly mentioned POPs are organochlorine pesticides, such as DDT, industrial chemicals, most notably polychlorinated biphenyls (PCBs), and by-products, especially polychlorinated dibenzodioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs). As a group, POPs are of concern for both the environment and human health 1.
With the ratification of the Stockholm Convention on POPs in early 2004, the international community signaled its commitment to reduce or eliminate production and emission of POPs into the environment and ultimately, the human body. There were 12 POPs initially listed under the Convention in 2004 2. The Convention is effective to the People's Republic of China, including the Hong Kong Special Administrative Region (HKSAR). The Environmental Protection Department (EPD) coordinates the HKSAR Government's efforts for the Convention and prepared the HKSAR Implementation Plan 3, in which the Department of Health (DH) is required to conduct the regular local monitoring of POPs in human milk.
The first study of POPs in human milk by DH was conducted during 2008 to 2011, which was made reference to Guidelines for Developing a National Protocol of the Fourth World Health Organization (WHO) - Coordinated Survey of Human Milk for POPs in Cooperation with United Nations Environment Programme (UN Environment) (2007) 4.
Results of the first study by DH was published in a scientific journal 5 and submitted to EPD, which were also discussed in the HKSAR Implementation Plan for the Stockholm Convention on POPs (2016) 5. Compared to the related earlier local studies 7,8,9 conducted by local universities, levels of POPs in human milk had declined over time.
Mothers should be reassured that breast milk is naturally the superior food for infants. The study is intended to provide data to evaluate the effectiveness of the international agreement, i.e. the Stockholm Convention, which aims to reduce the levels of certain POPs in our environment.
The study will also support national capabilities for monitoring and sound management of POPs.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mothers under 30 | – | Other: no interventionno intervention will be administered |
Who may qualify
- Ages
- Up to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Fifty eligible participants (nursing mothers) will be identified during their postnatal visits at four selected Maternal Child Health Centres (MCHCs) of the Department of Health, representing four major regions in Hong Kong: Sai Ying Pun MCHC (Hong Kong Island); Kowloon City MCHC (Kowloon); Madam Yung Fung Shee MCHC (New Territories West); and Ma On Shan MCHC (New Territories East). If the recruitment is unsatisfactory in the above four centres, other MCHCs will be involved.
Key inclusion criteria (7 listed)
- Primiparae;
- 30 years of age or below;
- Have normal pregnancy;
- Breastfeeding one infant only, and not multiple pregnancy;
- Resided in Hong Kong for at least 10 years immediately before the date of interview;
Key exclusion criteria (1 listed)
- participants with previously diagnosed major diseases such as hepatitis, AIDS and other such diseases shall be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Mothers under 30 |
Primary outcome
Amount of persistent organic pollutants in breast milk
Time frame: 2 years
Approximately 30 types of persistent organic pollutants will be tested
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 23 Oct 2026.
- Individual participant dataSharing planned: No
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Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"
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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.
Lap Ah Tse principal investigator
Chinese University of Hong Kong
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 Milk Collection, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 1 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 23 Oct 2026. 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 Hong Kong. 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?
Amount of persistent organic pollutants in breast milk (time frame: 2 years). 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 23 Oct 2026.