Skip to main content
OpenTrials
Completed

NCT Number: NCT02719262

Reduced of Ambient Melamine Exposure by Melamine Workplace Intervention

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Environmental Exposure

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

installing ventilation in the workplace

Device

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

Primary outcomes

  1. Change of melamine in air and in urine

    Time frame: 1 weeks

    Measured by liquid chromatograph/tandem mass spectrometry

Secondary outcomes

  1. Oxidative stress markers 8-hydoxy-2-deoxyguanosine (8-OHdG)

    Time frame: 6 months

    Urinary 8-OHdG concentration was measured using a validated method of online SPE LC-MS/MS.

  2. oxidative stress markers malondialdehyde (MDA)

    Time frame: 6 months

    Urinary MDA was measured by using HPLC-FL with a reversed-phase column.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 25, 2016
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.