NCT05950386

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

July 11, 2023

Last Update Submit

July 19, 2023

Conditions

Keywords

FerroptosisNrf2Iron metabolismLead exposureNeurotoxicity

Outcome Measures

Primary Outcomes (3)

  • Concentration of TNF-α level in peripheral blood

    Biomarkers of the proinflammatory cytokines

    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

    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

    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

Study Arms (2)

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

Other: Lead exposure

Interventions

The lead-acid battery factory workers will exposure to lead via Inhalation of lead particles, ingestion of lead-contaminated dust and water.

The lead exposure group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Aged over 18 years old
  • Work for the lead acid battery factory more than 10 years

You may not qualify if:

  • Neurological disorders
  • Endocrine diseases
  • Cancer
  • Exposure to any chemical pollutant before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenjing Zhao

Yangzhou, Jiangsu, 225001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The enrolled participant's peripheral whole blood samples

MeSH Terms

Conditions

Lead PoisoningNeurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Heavy Metal PoisoningPoisoningChemically-Induced DisordersNervous System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 18, 2023

Study Start

July 1, 2023

Primary Completion

August 10, 2023

Study Completion

September 25, 2023

Last Updated

July 21, 2023

Record last verified: 2023-07

Locations