the Study of Persistent Organic Pollutants in Human Milk

Breast Milk Collection Clinical Trial

Official title:

the Study of Persistent Organic Pollutants in Human Milk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04102085
• Other study ID #: DH/SEB/NCD/18/2018-19
• Status: Recruiting
• Start date: September 25, 2019
• Est. completion date: October 25, 2021

Study information

• Verified date: December 2020
• Source: Chinese University of Hong Kong
• Contact: Bonnie Kwok
• Phone: 22528795
• Email: bonniekwokhl[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 25, 2021
• Est. primary completion date: September 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 30 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• participants with previously diagnosed major diseases such as hepatitis, AIDS and other such diseases shall be excluded from the study

Related Conditions & MeSH terms

• Breast Milk Collection

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
Hong Kong	Bonnie Kwok	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of persistent organic pollutants in breast milk	Approximately 30 types of persistent organic pollutants will be tested	2 years