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Reduced of Ambient Melamine Exposure by Melamine Workplace Intervention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02719262
Enrollment
24
Registered
2016-03-25
Start date
2016-03-26
Completion date
2016-12-30
Last updated
2018-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Environmental Exposure

Keywords

Melamine, Renal damage, Workplace intervention

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.

Interventions

DEVICEinstalling ventilation in the workplace

Environmental improvement by installing/ exhaust ventilation (FUDIN SYSTEM ENGINEERING CO.,LTD.)

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Masking description

Blinded by lab. persons who analyzed biomarkers

Intervention model description

Install local ventilation or not

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change of melamine in air and in urine1 weeksMeasured by liquid chromatograph/tandem mass spectrometry

Secondary

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026