Reduced of Ambient Melamine Exposure by Melamine Workplace Intervention

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02719262

Collaborator

(none)

Enrollment

Location

Arm

9.2

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Environmental Exposure	Device: installing ventilation in the workplace	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Install local ventilation or notInstall local ventilation or not

Masking:

None (Open Label)

Masking Description:

Blinded by lab. persons who analyzed biomarkers

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 26, 2016

Actual Primary Completion Date :

Nov 20, 2016

Actual Study Completion Date :

Dec 30, 2016

Arms and Interventions

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.)

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.)

Outcome Measures

Primary Outcome Measures

Change of melamine in air and in urine [1 weeks]
Measured by liquid chromatograph/tandem mass spectrometry

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Medical University	Kaohsiung		Taiwan	807

Sponsors and Collaborators

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ming-Tsang Wu, Director of Center of Environmental & Occupational Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital

ClinicalTrials.gov Identifier:

NCT02719262

Other Study ID Numbers:

KMU-F105002

First Posted:

Mar 25, 2016

Last Update Posted:

Sep 26, 2018

Last Verified:

Sep 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Ming-Tsang Wu, Director of Center of Environmental & Occupational Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital

Melamine

Renal damage

Workplace intervention

Study Results

No Results Posted as of Sep 26, 2018