NCT02719262

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

March 26, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

March 16, 2016

Last Update Submit

September 24, 2018

Conditions

Environmental Exposure

Keywords

MelamineRenal damageWorkplace intervention

Outcome Measures

Primary Outcomes (1)

  • Change of melamine in air and in urine

    Measured by liquid chromatograph/tandem mass spectrometry

    1 weeks

Secondary Outcomes (2)

  • Oxidative stress markers 8-hydoxy-2-deoxyguanosine (8-OHdG)

    6 months

  • oxidative stress markers malondialdehyde (MDA)

    6 months

Study Arms (1)

Intervention

EXPERIMENTAL

installing ventilation in the workplace

Device: installing ventilation in the workplace

Interventions

installing ventilation in the workplaceDEVICE

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

Intervention

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adult over age of 20 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

Location

Study Officials

  • Ming-Tsang Wu, MD, ScD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Blinded by lab. persons who analyzed biomarkers
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Install local ventilation or not
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Center of Environmental & Occupational Medicine

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 25, 2016

Study Start

March 26, 2016

Primary Completion

November 20, 2016

Study Completion

December 30, 2016

Last Updated

September 26, 2018

Record last verified: 2018-09

Locations

TW(1)