<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/NCT04426994</url>
  </required_header>
  <id_info>
    <org_study_id>PPI HypoMg</org_study_id>
    <nct_id>NCT04426994</nct_id>
  </id_info>
  <brief_title>Hypomagnesemia Associated With Proton-Pump Inhibitor Use</brief_title>
  <acronym>PPI_HypoMg</acronym>
  <official_title>Hypomagnesemia Associated With Proton-Pump Inhibitor Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changi General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changi General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Use of proton pump inhibitors has been associated with hypomagnesemia. However, various&#xD;
      case-control or prospective studies have found conflicting results with regards to proton&#xD;
      pump inhibitors use and development of hypomagnesemia. Our aim was to evaluate the likelihood&#xD;
      that proton pump inhibitors contributed to severe hypomagnesemia in a retrospective cohort of&#xD;
      patients admitted with severe hypomagenesemia. We also aimed to look for risk factors leading&#xD;
      to development of hypomagnesemia amongst users of proton pump inhibitors&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2017</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hypomagnesemia due to use with proton pump inhibitor</measure>
    <time_frame>2013 to 2016</time_frame>
    <description>Number of patients with Hypomagnesemia related to use of proton pump inhibitor using Naranjo score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors for Hypomagnesemia</measure>
    <time_frame>2013 to 2016</time_frame>
    <description>Odds ratio of developing Hypomagnesemia with risk factors of age, gender, type of drug, dose of drug, chronic renal failure, use of diuretics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypocalcaemia</measure>
    <time_frame>2013 to 2016</time_frame>
    <description>Number of patients developing hypocalcemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypokalemia</measure>
    <time_frame>2013 to 2016</time_frame>
    <description>Number of patients developing Hypokalemia</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">211672</enrollment>
  <condition>Proton Pump Inhibitor Adverse Reaction</condition>
  <condition>Hypomagnesemia</condition>
  <condition>Arrhythmias, Cardiac</condition>
  <condition>Seizures</condition>
  <condition>Hypocalcemia</condition>
  <condition>Hypokalemia</condition>
  <arm_group>
    <arm_group_label>Case</arm_group_label>
    <description>Patients admitted with hypomagnesemia are evaluated for proton pump inhibitor use and likelihood of hypomagnesemia due to proton pump inhibitor use</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Patients on long-term proton pump inhibitor without documented hypomagnesemia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>proton pump inhibitor use</intervention_name>
    <description>Patients using long term proton pump inhibitor</description>
    <arm_group_label>Case</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients managed at a referral centre from 2013 - 2016. Cases were admitted to the referral&#xD;
        centre and had documentation hypomagnesemia. Controls were prescribed a course of proton&#xD;
        pump inhibitor during the same period&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted with hypomagnesemia (cases)&#xD;
&#xD;
          -  Patients prescribed with proton pump inhibitors (controls)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients prescribed with less than three months duration of proton pump inhibitors&#xD;
             (controls)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Troy H Puar, MRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changi General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Changi General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>529889</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Hypocalcemia</mesh_term>
    <mesh_term>Hypokalemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Proton Pump Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Anonymised pooled data</ipd_description>
  </patient_data>
  <!-- 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/NCT04426994
org study id: PPI HypoMg
nct id: NCT04426994
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Use of proton pump inhibitors has been associated with hypomagnesemia. However, various
      case-control or prospective studies have found conflicting results with regards to proton
      pump inhibitors use and development of hypomagnesemia. Our aim was to evaluate the likelihood
      that proton pump inhibitors contributed to severe hypomagnesemia in a retrospective cohort of
      patients admitted with severe hypomagenesemia. We also aimed to look for risk factors leading
      to development of hypomagnesemia amongst users of proton pump inhibitors
observational model: Case-Control
time perspective: Retrospective
measure: Hypomagnesemia due to use with proton pump inhibitor
time frame: 2013 to 2016
description: Number of patients with Hypomagnesemia related to use of proton pump inhibitor using Naranjo score
measure: Risk factors for Hypomagnesemia
time frame: 2013 to 2016
description: Odds ratio of developing Hypomagnesemia with risk factors of age, gender, type of drug, dose of drug, chronic renal failure, use of diuretics
measure: Hypocalcaemia
time frame: 2013 to 2016
description: Number of patients developing hypocalcemia
measure: Hypokalemia
time frame: 2013 to 2016
description: Number of patients developing Hypokalemia
arm group label: Case
description: Patients admitted with hypomagnesemia are evaluated for proton pump inhibitor use and likelihood of hypomagnesemia due to proton pump inhibitor use
arm group label: Control
description: Patients on long-term proton pump inhibitor without documented hypomagnesemia
intervention type: Drug
intervention name: proton pump inhibitor use
description: Patients using long term proton pump inhibitor
arm group label: Case
arm group label: Control
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 100 Years
last name: Troy H Puar, MRCP
role: Principal Investigator
affiliation: Changi General Hospital
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Seizures
mesh term: Arrhythmias, Cardiac
mesh term: Hypocalcemia
mesh term: Hypokalemia
mesh term: Proton Pump Inhibitors
sharing ipd: Undecided
ipd description: Anonymised pooled data