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CompletedNCT02251405BidmeUpdated Oct 21, 2014

Behaviour Intervention to Decrease Melamine Exposure

An interventional study of One bag, stainless container in Healthy Subjects, sponsored by Ming-Tsang Wu. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-21.

Sponsored by Ming-Tsang Wu · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
20 Years to 30 Years
Sex
All
01

Study 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.

Read the detailed description

Study subjects:

Two tiers:

  1. Recruit 88 student volunteers from two university buildings and collect their morning one-spot urine specimens for 3 consecutive days (44 students in each building (Building A and Building B)
  2. Select appropriate study subjects with high excretion of urinary melamine and with consuming melamine tableware containing hot water or hot soup by questionnaire in the past 3 days for intervention.

Study protocol:

This is a cluster randomized crossover intervention. We will conduct this study for 9 days and each experimental step lasts for 3 days. We randomly assign one building with 8 appropriate study subjects to a serial of control-intervention-intervention steps and another building with also 8 appropriate study subjects to a serial of control-control-intervention steps. Intervention step means study subjects will carry one big bag containing two stainless containers, one stainless spoon, and one stainless chopstick and use them for each meal during the trial (Some subjects will need to take pictures randomly and email back before the meal). Control means study subjects will carry one big bag without those stainless container, spoon, and chopstick and only use the containers provided by vendors for each meal during the trial (Some subjects will need to take pictures randomly and email back before the meal to check their adherence). Collect 24-hr urine samples for 9 days for melamine levels.

Inclusion criteria: 20-30 healthy students Exclusion criteria: Subjects with cancer, hypertension, diabetes, chronic hepatic or renal diseases, including urinary tract infection, or renal stones; Family history of renal stones; Body weight less than 50 kg.

02

Conditions studied

  • Healthy Subjects

Keywords

  • Melamine
  • Melamine tableware
03

In context

Lead sponsor

This is the only study on the registry with Ming-Tsang Wu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 20-30-yrs healthy students

Exclusion criteria

Exclusion Criteria:

  • Subjects with cancer, hypertension, diabetes, chronic hepatic or renal diseases, renal stones;
  • Family history of renal stones;
  • Body weight less than 50 kg.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Placebo comparator
    One big bag, no stainless container

    No stainless container

    Behavioral: One bag, stainless container

  • Active comparator
    One big bag with two stainless containers

    Two stainless containers

    Behavioral: One bag, stainless container

Interventions

  • BehavioralOne bag, stainless container
06

What researchers measure

Primary outcomes

  1. Decrease melamine excretion

    Time frame: 3 days

07

Study locations

1 site
  • Kaohsiung Medical University
    Kaohsiung City, 807, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02251405
Lead sponsor
Ming-Tsang Wu
Responsible party
Ming-Tsang Wu (Professor, Kaohsiung Medical University Chung-Ho Memorial Hospital) — Sponsor-investigator
First posted
Sep 29, 2014
Start date
Oct 2014
Primary completion
Oct 2014
Completion
Oct 2014
Last update
Oct 21, 2014

Study contacts

Ming-Tsang Wu, MD, ScD
principal investigator · Kaohsiung Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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