Reduced of Ambient Melamine Exposure by Melamine Workplace Intervention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Environmental Exposure

Intervention / Treatment
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* Device: installing ventilation in the workplace


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Install local ventilation or not
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of melamine in air and in urine | 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) | Urinary 8-OHdG concentration was measured using a validated method of online SPE LC-MS/MS. | 6 months | 
| oxidative stress markers malondialdehyde (MDA) | Urinary MDA was measured by using HPLC-FL with a reversed-phase column. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melamine, Renal damage, Workplace intervention