<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/NCT02235948</url>
  </required_header>
  <id_info>
    <org_study_id>Y211045</org_study_id>
    <nct_id>NCT02235948</nct_id>
  </id_info>
  <brief_title>Effects of Folic Acid Supplementation on Arsenic Lowering</brief_title>
  <official_title>Efficacy and Safety of Folic Acid Supplementation Lowering Arsenic in a Chronic, Low-level Exposed Arsenic Population: a Randomized, Double-blind, Placebo Controlled Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether folic acid supplementation are effective on&#xD;
      arsenic lowering in a chronic, low-level arsenic exposed population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Outcome measure:&#xD;
&#xD;
      Changes of arsenic metabolites at baseline and week 8&#xD;
&#xD;
      Methods High-performance liquid chromatography (HPLC)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of urine arsenic metabolites between baseline and week 8</measure>
    <time_frame>baseline, week 8</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Arsenic Poisoning</condition>
  <condition>Toxic Effect of Arsenic and Its Compounds</condition>
  <arm_group>
    <arm_group_label>folic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>folic acid supplementation placebo controlled</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>folic acid supplementation</intervention_name>
    <description>0.8mg folic acid/day</description>
    <arm_group_label>folic acid</arm_group_label>
    <other_name>placebo controlled</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women more than 18 years of age and chronically exposed to arsenic (arsenic&#xD;
             concentration of the drinking water &gt;10ug/L);&#xD;
&#xD;
          -  Population who had no folic acid supplementation in the 2 weeks before the study;&#xD;
&#xD;
          -  Women of childbearing age agreed to use a reliable contraception method during the&#xD;
             study;&#xD;
&#xD;
          -  Everyone volunteered to participate and signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding women;&#xD;
&#xD;
          -  Allergic to folic acid;&#xD;
&#xD;
          -  Having clearly defined allergic history;&#xD;
&#xD;
          -  Reported long-term use of folic acid and other vitamins B;&#xD;
&#xD;
          -  Having obvious signs or laboratory abnormalities which could affect the efficacy of&#xD;
             folic acid;&#xD;
&#xD;
          -  Unsuitable to participate in the study based on the judgment of the investigators;&#xD;
&#xD;
          -  Not agree to cancel the medications which may affect serum folate concentration during&#xD;
             the study period;&#xD;
&#xD;
          -  Subjects who plan to become pregnant during the study or move out of the area within&#xD;
             the study period;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiao Xiao, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Wenzhou Medical University</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>Xiao Xiao</investigator_full_name>
    <investigator_title>MD, PhD, professor</investigator_title>
  </responsible_party>
  <keyword>arsenic induced health problem</keyword>
  <keyword>modifying effects</keyword>
  <keyword>folic acid</keyword>
  <keyword>oxidative damage</keyword>
  <keyword>clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arsenic Poisoning</mesh_term>
    <mesh_term>Poisoning</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Folic Acid</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02235948
org study id: Y211045
nct id: NCT02235948
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether folic acid supplementation are effective on
      arsenic lowering in a chronic, low-level arsenic exposed population.
Outcome measure:

      Changes of arsenic metabolites at baseline and week 8

      Methods High-performance liquid chromatography (HPLC)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change of urine arsenic metabolites between baseline and week 8
time frame: baseline, week 8
arm group label: folic acid
arm group type: Experimental
description: folic acid supplementation placebo controlled
intervention type: Drug
intervention name: folic acid supplementation
description: 0.8mg folic acid/day
arm group label: folic acid
other name: placebo controlled
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xiao Xiao, MD, PhD
role: Study Director
affiliation: Wenzhou Medical University
responsible party type: Principal Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: Xiao Xiao
investigator title: MD, PhD, professor
mesh term: Arsenic Poisoning
mesh term: Poisoning
mesh term: Folic Acid