Reduced of Ambient Melamine Exposure by Melamine Workplace Intervention

Not Applicable

Completed

• Conditions: Environmental Exposure
• Interventions: Device: installing ventilation in the workplace

• Registration Number: NCT02719262
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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).

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 Timeline

• Study First Submitted: 2016-03-16
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-25
• Study Start: 2016-03-26
• Primary Completion: 2016-11-20
• Study Completion: 2016-12-30
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-24
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	installing ventilation in the workplace	installing ventilation in the workplace

Primary Outcome Measures

Name	Time	Method
Change of melamine in air and in urine	1 weeks	Measured by liquid chromatograph/tandem mass spectrometry

Secondary Outcome Measures

Name	Time	Method
oxidative stress markers malondialdehyde (MDA)	6 months	Urinary MDA was measured by using HPLC-FL with a reversed-phase column.
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.

Trial Locations

Locations (1)

Kaohsiung Medical University; 🇨🇳 Kaohsiung, Taiwan