Lead PoisoningNCT05950386
Effects of Lead Exposure on Ferroptosis Pathway
An observational study of Lead Poisoning and Neurotoxicity, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
The aim of this study was to investigate the effects of chronic lead exposure on iron metabolism and the Nrf2-dependent ferroptosis pathway in lead acid battery factory workers Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lead Poisoning, Neurotoxicity
- What is being tested?
- Lead exposure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 25 Sep 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The control group will be selected from the invited who live in Yangzhou city via the website, email, and poster. The lead exposure group will be selected from the invited volunteers who live in Yangzhou with the assistance of the Center for Disease Control and Prevention of Yangzhou, the website, email, and poster.
Who may be able to join
- Aged over 18 years old
- Work for the lead acid battery factory more than 10 years
Who cannot join
- Neurological disorders
- Endocrine diseases
- Cancer
- Exposure to any chemical pollutant before
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wenjing Zhao
Yangzhou, Jiangsu, 225001
wenjing zhao, +8618118206088, zhaowenjingmo@163.com
About this study
Official title: Effects of Lead Exposure on Iron Metabolism and the Nrf2-dependent Ferroptosis Pathway
The aim of this study was to investigate the effects of chronic lead exposure on iron metabolism and the Nrf2-dependent ferroptosis pathway in lead acid battery factory workers
Read the detailed description
Background:
Lead (Pb) is a prevalent and highly toxic heavy metal. Human activities have been the primary cause of lead contamination in the environment over the past century. Lead exposure poses a global concern, particularly for children, and individuals can be exposed to lead through various means, such as contaminated soil, dust, food, water, or foreign objects. The central nervous system (CNS) is particularly vulnerable to the toxic effects of lead (Pb), especially in children, primarily due to the immaturity of the blood-brain barrier.
Ferroptosis is a recently defined form of regulated cell death characterized by iron-dependent cell death resulting from the accumulation of lipid hydroperoxides. However, the exact mechanism underlying the neurotoxic effects of chronic low-level lead exposure-induced ferroptosis on neuronal injury is not yet fully understood.
Methods:
The investigators first analyze the difference of blood lead level using atomic absorption spectrometry.
The investigators enrolled 20 chronic lead exposure workers from a lead acid battery factory and an age-matched control group of non-lead-exposed workers.
TNF-α elisa kit was used to compare the proinflammatory cytokines in two groups.
Quantitative reverse transcription PCR (Polymerase Chain Reaction) was used to compare messenger ribonucleic acid (mRNA) expression of iron metabolism (FTH1, FPN1, DMT1) and the Nrf2-dependent ferroptosis pathway (Nrf2, SLC7A11, GPX4)
Detailed Methods protocol
- The criteria of enrolled chronic lead exposure participants were as follows：inclusion: work for this lead acid battery factory more than 10 year; exclusion: exposure to any chemistry pollution before; neurological disorders; endocrine diseases; cancer
- Sample collection: at the end of recruitment in this study, all of the enrolled participant will come to the hospital to collect peripheral Blood (Northern Jiangsu People's Hospital, affiliated with Yangzhou University), and the blood samples will be collected into EDTA (ethyleneDiamine tetraacetic acid) vacutainer tubes and then divided into leukocytes and plasma for further experiments.
- TNF-α ELISA KIT: Plasma TNF-α concentrations were detected by the competitive ELISA method
- Primer sequence used in this study:
1.DMT1 forward: 5'-CTAGACTGGGAGTGGTTACTGG-3' DMT1 reverse: 5'-AGGATGACTCGTGGGACCTT-3' 2.FTH1 forward: 5'-CTGGTGGCCGAATCTTCCTTCA-3' FTH1 reverse: 5'-GCCAGTTTGTGCAGTTCCAG-3' 3.FPN1 forward: 5'-CTACTTGGGGAGATCGGATGT-3' FPN1 reverse: 5'-CTGGGCCACTTTAAGTCTAGC-3' 4.GPX4 forward: 5'-GAGGCAAGACCGAAGTAAACTAC-3' GPX4 reverse: 5'-CCGAACTGGTTACACGGGAA-3' 5.SLC7A11 forward: 5'-TCTCCAAAGGAGGTTACCTGC-3' SLC7A11 reverse: 5'-AGACTCCCCTCAGTAAAGTGAC-3' 6. Nrf2 forward 5'-ATAGCTGAGCCCAGTATC-3' Nrf2 reverse 5'- CATGCACGTGAGTGCTCT-3' 7. GAPDH forward: 5'-GGAGCGAGATCCCTCCAAAAT-3' GAPDH reverse: 5'-GGCTGTTGTCATACTTCTCATGG-3'
- Conditions
- Lead Poisoning, Neurotoxicity
- Being tested
- Lead exposure
- Keywords
- Ferroptosis, Nrf2, Iron metabolism, Lead exposure, Neurotoxicity
- Medical subject headings
- Lead Poisoning, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lead exposureOther
The lead-acid battery factory workers will exposure to lead via Inhalation of lead particles, ingestion of lead-contaminated dust and water.
| Study group | Role | What they receive |
|---|---|---|
| The control group | The invited non-lead-exposed workers live in Yangzhou, Jiangsu, China | |
| The lead exposure group | The invited chronic-lead exposed workers live in Yangzhou, Jiangsu, China Receives: Other: Lead exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of TNF-α level in peripheral blood
Biomarkers of the proinflammatory cytokines
Measured: From the date of all participants documented baseline data, until the date of the last participant documented the changes of biomarkers in peripheral blood, assessed up to 60 days
The relative mRNA expression rate of the Nrf2- dependent ferroptosis genes in peripheral blood
Biomarkers of the Nrf2- dependent ferroptosis
Measured: From the date of all participants documented baseline data, until the date of the last participant documented the changes of biomarkers in peripheral blood, assessed up to 60 days
The relative mRNA expression rate of the iron metabolism genes in peripheral blood
Biomarkers of the iron metabolism
Measured: From the date of all participants documented baseline data, until the date of the last participant documented the changes of biomarkers in peripheral blood, assessed up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jul 2023
- Primary completion10 Aug 2023 (estimated)
- Study completion25 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lead PoisoningStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, WenJing Zhao, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950386
- Sponsor's protocol ID
- Lead exposure
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lead Exposure on Iron Metabolism and the Nrf2-dependent Ferroptosis Pathway
- ClinicalTrials.gov ID
- NCT05950386
- Acronym / sponsor ID
- Lead exposure
- Conditions
- Lead Poisoning, Neurotoxicity
- Keywords
- Ferroptosis, Nrf2, Iron metabolism, Lead exposure, Neurotoxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 10 Aug 2023 (estimated)
- Study completion
- 25 Sep 2023 (estimated)
- First posted
- 18 Jul 2023 (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 aim of this study was to investigate the effects of chronic lead exposure on iron metabolism and the Nrf2-dependent ferroptosis pathway in lead acid battery factory workers
Detailed description
Background:
Lead (Pb) is a prevalent and highly toxic heavy metal. Human activities have been the primary cause of lead contamination in the environment over the past century. Lead exposure poses a global concern, particularly for children, and individuals can be exposed to lead through various means, such as contaminated soil, dust, food, water, or foreign objects. The central nervous system (CNS) is particularly vulnerable to the toxic effects of lead (Pb), especially in children, primarily due to the immaturity of the blood-brain barrier.
Ferroptosis is a recently defined form of regulated cell death characterized by iron-dependent cell death resulting from the accumulation of lipid hydroperoxides. However, the exact mechanism underlying the neurotoxic effects of chronic low-level lead exposure-induced ferroptosis on neuronal injury is not yet fully understood.
Methods:
The investigators first analyze the difference of blood lead level using atomic absorption spectrometry.
The investigators enrolled 20 chronic lead exposure workers from a lead acid battery factory and an age-matched control group of non-lead-exposed workers.
TNF-α elisa kit was used to compare the proinflammatory cytokines in two groups.
Quantitative reverse transcription PCR (Polymerase Chain Reaction) was used to compare messenger ribonucleic acid (mRNA) expression of iron metabolism (FTH1, FPN1, DMT1) and the Nrf2-dependent ferroptosis pathway (Nrf2, SLC7A11, GPX4)
Detailed Methods protocol
- The criteria of enrolled chronic lead exposure participants were as follows：inclusion: work for this lead acid battery factory more than 10 year; exclusion: exposure to any chemistry pollution before; neurological disorders; endocrine diseases; cancer
- Sample collection: at the end of recruitment in this study, all of the enrolled participant will come to the hospital to collect peripheral Blood (Northern Jiangsu People's Hospital, affiliated with Yangzhou University), and the blood samples will be collected into EDTA (ethyleneDiamine tetraacetic acid) vacutainer tubes and then divided into leukocytes and plasma for further experiments.
- TNF-α ELISA KIT: Plasma TNF-α concentrations were detected by the competitive ELISA method
- Primer sequence used in this study:
1.DMT1 forward: 5'-CTAGACTGGGAGTGGTTACTGG-3' DMT1 reverse: 5'-AGGATGACTCGTGGGACCTT-3' 2.FTH1 forward: 5'-CTGGTGGCCGAATCTTCCTTCA-3' FTH1 reverse: 5'-GCCAGTTTGTGCAGTTCCAG-3' 3.FPN1 forward: 5'-CTACTTGGGGAGATCGGATGT-3' FPN1 reverse: 5'-CTGGGCCACTTTAAGTCTAGC-3' 4.GPX4 forward: 5'-GAGGCAAGACCGAAGTAAACTAC-3' GPX4 reverse: 5'-CCGAACTGGTTACACGGGAA-3' 5.SLC7A11 forward: 5'-TCTCCAAAGGAGGTTACCTGC-3' SLC7A11 reverse: 5'-AGACTCCCCTCAGTAAAGTGAC-3' 6. Nrf2 forward 5'-ATAGCTGAGCCCAGTATC-3' Nrf2 reverse 5'- CATGCACGTGAGTGCTCT-3' 7. GAPDH forward: 5'-GGAGCGAGATCCCTCCAAAAT-3' GAPDH reverse: 5'-GGCTGTTGTCATACTTCTCATGG-3'
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | – | –The invited non-lead-exposed workers live in Yangzhou, Jiangsu, China |
| The lead exposure group | – | Other: Lead exposureThe invited chronic-lead exposed workers live in Yangzhou, Jiangsu, China |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The control group will be selected from the invited who live in Yangzhou city via the website, email, and poster. The lead exposure group will be selected from the invited volunteers who live in Yangzhou with the assistance of the Center for Disease Control and Prevention of Yangzhou, the website, email, and poster.
Key inclusion criteria (2 listed)
- Aged over 18 years old
- Work for the lead acid battery factory more than 10 years
Key exclusion criteria (4 listed)
- Neurological disorders
- Endocrine diseases
- Cancer
- Exposure to any chemical pollutant before
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 |
|---|---|---|
| Lead exposureThe lead-acid battery factory workers will exposure to lead via Inhalation of lead particles, ingestion of lead-contaminated dust and water. | Other | The lead exposure group |
Primary outcome
Concentration of TNF-α level in peripheral blood
Time frame: From the date of all participants documented baseline data, until the date of the last participant documented the changes of biomarkers in peripheral blood, assessed up to 60 days
Biomarkers of the proinflammatory cytokines
The relative mRNA expression rate of the Nrf2- dependent ferroptosis genes in peripheral blood
Time frame: From the date of all participants documented baseline data, until the date of the last participant documented the changes of biomarkers in peripheral blood, assessed up to 60 days
Biomarkers of the Nrf2- dependent ferroptosis
The relative mRNA expression rate of the iron metabolism genes in peripheral blood
Time frame: From the date of all participants documented baseline data, until the date of the last participant documented the changes of biomarkers in peripheral blood, assessed up to 60 days
Biomarkers of the iron metabolism
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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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.
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 Lead Poisoning and Neurotoxicity, run by Northern Jiangsu People's Hospital 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ju Gao (+8618118206088, gaoju_003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of TNF-α level in peripheral blood (time frame: From the date of all participants documented baseline data, until the date of the last participant documented the changes of biomarkers in peripheral blood, assessed up to 60 days). The study lists 3 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 21 Jul 2023.