NCT02251405

Brief Summary

One source of melamine exposure in the modern life is from the use of melamine tableware. This study examines whether the use of stainless steel containers can decrease melamine exposure in the daily life. The investigators hypothesize that, compared to those without use of stainless steel containers, university student volunteers with use of stainless steel containers excrete significantly lower melamine levels in urine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

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

August 8, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

Same day

First QC Date

August 8, 2014

Last Update Submit

October 20, 2014

Conditions

Healthy Subjects

Keywords

MelamineMelamine tableware

Outcome Measures

Primary Outcomes (1)

  • Decrease melamine excretion

    3 days

Study Arms (2)

One big bag, no stainless container

PLACEBO COMPARATOR

No stainless container

Behavioral: One bag, stainless container

One big bag with two stainless containers

ACTIVE COMPARATOR

Two stainless containers

Behavioral: One bag, stainless container

Interventions

One bag, stainless containerBEHAVIORAL
One big bag with two stainless containersOne big bag, no stainless container

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • yrs healthy students

You may not qualify if:

  • Subjects with cancer, hypertension, diabetes, chronic hepatic or renal diseases, renal stones;
  • Family history of renal stones;
  • Body weight less than 50 kg.

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
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2014

First Posted

September 29, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 21, 2014

Record last verified: 2014-10

Locations

TW(1)