Reduced of Ambient Melamine Exposure by Melamine Workplace Intervention

September 24, 2018 updated by: Ming-Tsang Wu, Kaohsiung Medical University Chung-Ho Memorial Hospital

Workplace Intervention and Reduced Ambient Melamine Exposure and Renal Damage in Melamine Tableware Manufacturing Workers

The investigators recent study has found that ambient melamine exposure can cause the increase of biomarkers of renal tubular injury in melamine manufacturing workers. Thus, in this year, the investigators will examine whether the intervention by installing ventilation in the workplace and providing personal protective equipment and education can decrease ambient melamine exposure and further decrease urinary biomarkers of renal tubular injury such as N-acetyl β-D-glucosaminidase (NAG) and β2-microglobulin (β2-MG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators through intervention trial design to examine whether the use of ventilation in the workplace can decrease ambient melamine exposure, oxidative stress markers (such as 8-hydoxy-2-deoxyguanosine, malondialdehyde)and indicators of early renal damage (such as N-acetyl β-D-glucosaminidase, microalbumin and β2-microglobulin). The one week before intervention and the second week after intervention, the volunteers were asked to collect their urine samples for one consecutive week during mornings and afternoons. Blood samples were taken on Fridays morning, workplace air was sampled for 5 consecutive days. Then the investigators continued to trace the melamine concentration change of volunteers and workplace every three-month intervals after intervention, and blood samples were taken on 12th and 24th month.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy adult over age of 20 years

Exclusion Criteria:

  • any hormone treatment or major chronic diseases (such as: cancer, hypertension, diabetes, chronic kidney disease and chronic liver disease) and patients with urinary calculi or family history of urinary calculi

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
installing ventilation in the workplace
Device: installing ventilation in the workplace
Environmental improvement by installing/ exhaust ventilation (FUDIN SYSTEM ENGINEERING CO.,LTD.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of melamine in air and in urine
Time Frame: 1 weeks
Measured by liquid chromatograph/tandem mass spectrometry
1 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxidative stress markers 8-hydoxy-2-deoxyguanosine (8-OHdG)
Time Frame: 6 months
Urinary 8-OHdG concentration was measured using a validated method of online SPE LC-MS/MS.
6 months
oxidative stress markers malondialdehyde (MDA)
Time Frame: 6 months
Urinary MDA was measured by using HPLC-FL with a reversed-phase column.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Principal Investigator: Ming-Tsang Wu, MD, ScD, Kaohsiung Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2016

Primary Completion (Actual)

November 20, 2016

Study Completion (Actual)

December 30, 2016

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Actual)

September 26, 2018

Last Update Submitted That Met QC Criteria

September 24, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KMU-F105002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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