<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02251405</url>
  </required_header>
  <id_info>
    <org_study_id>KMU-DT103004</org_study_id>
    <secondary_id>KMU-DT103004</secondary_id>
    <nct_id>NCT02251405</nct_id>
  </id_info>
  <brief_title>Behaviour Intervention to Decrease Melamine Exposure</brief_title>
  <acronym>Bidme</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Ming-Tsang Wu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      One source of melamine exposure in the modern life is from the use of melamine tableware.&#xD;
      This study examines whether the use of stainless steel containers can decrease melamine&#xD;
      exposure in the daily life. The investigators hypothesize that, compared to those without use&#xD;
      of stainless steel containers, university student volunteers with use of stainless steel&#xD;
      containers excrete significantly lower melamine levels in urine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study subjects:&#xD;
&#xD;
      Two tiers:&#xD;
&#xD;
        1. Recruit 88 student volunteers from two university buildings and collect their morning&#xD;
           one-spot urine specimens for 3 consecutive days (44 students in each building (Building&#xD;
           A and Building B)&#xD;
&#xD;
        2. Select appropriate study subjects with high excretion of urinary melamine and with&#xD;
           consuming melamine tableware containing hot water or hot soup by questionnaire in the&#xD;
           past 3 days for intervention.&#xD;
&#xD;
      Study protocol:&#xD;
&#xD;
      This is a cluster randomized crossover intervention. We will conduct this study for 9 days&#xD;
      and each experimental step lasts for 3 days. We randomly assign one building with 8&#xD;
      appropriate study subjects to a serial of control-intervention-intervention steps and another&#xD;
      building with also 8 appropriate study subjects to a serial of control-control-intervention&#xD;
      steps. Intervention step means study subjects will carry one big bag containing two stainless&#xD;
      containers, one stainless spoon, and one stainless chopstick and use them for each meal&#xD;
      during the trial (Some subjects will need to take pictures randomly and email back before the&#xD;
      meal). Control means study subjects will carry one big bag without those stainless container,&#xD;
      spoon, and chopstick and only use the containers provided by vendors for each meal during the&#xD;
      trial (Some subjects will need to take pictures randomly and email back before the meal to&#xD;
      check their adherence). Collect 24-hr urine samples for 9 days for melamine levels.&#xD;
&#xD;
      Inclusion criteria: 20-30 healthy students Exclusion criteria: Subjects with cancer,&#xD;
      hypertension, diabetes, chronic hepatic or renal diseases, including urinary tract infection,&#xD;
      or renal stones; Family history of renal stones; Body weight less than 50 kg.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease melamine excretion</measure>
    <time_frame>3 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>One big bag, no stainless container</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>No stainless container</description>
  </arm_group>
  <arm_group>
    <arm_group_label>One big bag with two stainless containers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Two stainless containers</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>One bag, stainless container</intervention_name>
    <arm_group_label>One big bag with two stainless containers</arm_group_label>
    <arm_group_label>One big bag, no stainless container</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20-30-yrs healthy students&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with cancer, hypertension, diabetes, chronic hepatic or renal diseases, renal&#xD;
             stones;&#xD;
&#xD;
          -  Family history of renal stones;&#xD;
&#xD;
          -  Body weight less than 50 kg.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming-Tsang Wu, MD, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaohsiung Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Medical University</name>
      <address>
        <city>Kaohsiung</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>October 20, 2014</last_update_submitted>
  <last_update_submitted_qc>October 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kaohsiung Medical University Chung-Ho Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Ming-Tsang Wu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Melamine</keyword>
  <keyword>Melamine tableware</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02251405
org study id: KMU-DT103004
secondary id: KMU-DT103004
nct id: NCT02251405
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Decrease melamine excretion
time frame: 3 days
arm group label: One big bag, no stainless container
arm group type: Placebo Comparator
description: No stainless container
arm group label: One big bag with two stainless containers
arm group type: Active Comparator
description: Two stainless containers
intervention type: Behavioral
intervention name: One bag, stainless container
arm group label: One big bag with two stainless containers
arm group label: One big bag, no stainless container
criteria: 
gender: All
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ming-Tsang Wu, MD, ScD
role: Principal Investigator
affiliation: Kaohsiung Medical University
facility: 
country: Taiwan
responsible party type: Sponsor-Investigator
investigator affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
investigator full name: Ming-Tsang Wu
investigator title: Professor