Reduced of Ambient Melamine Exposure by Melamine Workplace Intervention

Environmental Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719262
• Other study ID #: KMU-F105002
• Status: Completed
• Phase: N/A
• Start date: March 26, 2016
• Est. completion date: December 30, 2016

Study information

• Verified date: September 2018
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 30, 2016
• Est. primary completion date: November 20, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Environmental Exposure

Intervention

Device:
• installing ventilation in the workplace
Environmental improvement by installing/ exhaust ventilation (FUDIN SYSTEM ENGINEERING CO.,LTD.)

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of melamine in air and in urine	Measured by liquid chromatograph/tandem mass spectrometry	1 weeks
Secondary	Oxidative stress markers 8-hydoxy-2-deoxyguanosine (8-OHdG)	Urinary 8-OHdG concentration was measured using a validated method of online SPE LC-MS/MS.	6 months
Secondary	oxidative stress markers malondialdehyde (MDA)	Urinary MDA was measured by using HPLC-FL with a reversed-phase column.	6 months