<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/NCT04412421</url>
  </required_header>
  <id_info>
    <org_study_id>Vitamin study 01</org_study_id>
    <nct_id>NCT04412421</nct_id>
  </id_info>
  <brief_title>Supplementation After Bariatric Surgery</brief_title>
  <official_title>Adherence to Vitamin and Mineral Supplementation After Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Östergötland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Östergötland</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess medication adherence to vitamin and mineral supplements&#xD;
      after bariatric surgery and identify factors that may influence adherence. All study&#xD;
      participants are prescribed life-long treatment with daily oral vitamin B12 and&#xD;
      Calcium/Vitamin-D. Menstruating women are also prescribed daily oral iron supplementation.&#xD;
      Post-operative adherence rate is retrieved from Pharmacy refill data, collected from the&#xD;
      Swedish Prescribed Drug Register, the five first years after bariatric surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to assess medication adherence to vitamin- and mineral&#xD;
      supplementation after bariatric surgery, identify factors that may influence adherence, as&#xD;
      well as study the development of micronutrient deficinencies detectable by blood sampling.&#xD;
&#xD;
      All study participants are prescribed life-long treatment with daily oral vitamin B12 and&#xD;
      Calcium/Vitamin-D. Menstruating women are also prescribed daily oral iron supplementation.&#xD;
&#xD;
      Post-operative adherence rate is retrieved from pharmacy refill data, collected from The&#xD;
      Swedish Prescribed Drug Register, at one, two and five years after bariatric surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 3, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to vitamin and mineral supplementation</measure>
    <time_frame>5 years</time_frame>
    <description>Implementation (Continuous multiple-interval measures of medication availability/gaps, CMA),</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to initiation</measure>
    <time_frame>1 year</time_frame>
    <description>Initiation (time to initiation)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to discontinuation</measure>
    <time_frame>5 years</time_frame>
    <description>Discontinuation (Time to discontinuation)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self reported Adherence to vitamin-and mineral supplementation</measure>
    <time_frame>5 years</time_frame>
    <description>Medication Adherence Report Scale (MARS-5) score 1-25, higher scores mean a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin (Hb)</measure>
    <time_frame>5 years</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron status</measure>
    <time_frame>5 years</time_frame>
    <description>µmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>s-folate</measure>
    <time_frame>5 years</time_frame>
    <description>nmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>p-calcium</measure>
    <time_frame>5 years</time_frame>
    <description>mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>s-albumin</measure>
    <time_frame>5 years</time_frame>
    <description>g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>s-cobolamin</measure>
    <time_frame>5 years</time_frame>
    <description>pmol/L</description>
  </secondary_outcome>
  <enrollment type="Actual">260</enrollment>
  <condition>Bariatric Surgery</condition>
  <condition>Micronutrient Deficiencies</condition>
  <condition>Obesity</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gastric Bypass, Sleeve Gastrectomy</intervention_name>
    <description>Lifelong vitamin and Mineral supplementation</description>
    <other_name>Vitamin and Mineral supplementation</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients subjected to bariatric surgery at Vrinnevi Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Patients subjected to bariatric surgery at Vrinnevi Hospital, Norrköping, Sweden&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to read and understand Swedish&#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>Ellen Andersson</last_name>
    <role>Principal Investigator</role>
    <affiliation>Region Östergötland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Surgery, Vrinnevi Hospital</name>
      <address>
        <city>Norrkoping</city>
        <zip>60379</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>February 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Östergötland</investigator_affiliation>
    <investigator_full_name>Ellen Andersson</investigator_full_name>
    <investigator_title>MD, PhD, Consultant Upper GI Surgeon</investigator_title>
  </responsible_party>
  <keyword>Bariatric Surgery (Gastric Bypass, Gastric Sleeve)</keyword>
  <keyword>Micronutrient Deficiencies</keyword>
  <keyword>Adherence, Medication</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04412421
org study id: Vitamin study 01
nct id: NCT04412421
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess medication adherence to vitamin and mineral supplements
      after bariatric surgery and identify factors that may influence adherence. All study
      participants are prescribed life-long treatment with daily oral vitamin B12 and
      Calcium/Vitamin-D. Menstruating women are also prescribed daily oral iron supplementation.
      Post-operative adherence rate is retrieved from Pharmacy refill data, collected from the
      Swedish Prescribed Drug Register, the five first years after bariatric surgery.
The aim of this study is to assess medication adherence to vitamin- and mineral
      supplementation after bariatric surgery, identify factors that may influence adherence, as
      well as study the development of micronutrient deficinencies detectable by blood sampling.

      All study participants are prescribed life-long treatment with daily oral vitamin B12 and
      Calcium/Vitamin-D. Menstruating women are also prescribed daily oral iron supplementation.

      Post-operative adherence rate is retrieved from pharmacy refill data, collected from The
      Swedish Prescribed Drug Register, at one, two and five years after bariatric surgery.
observational model: Cohort
time perspective: Prospective
measure: Adherence to vitamin and mineral supplementation
time frame: 5 years
description: Implementation (Continuous multiple-interval measures of medication availability/gaps, CMA),
measure: Time to initiation
time frame: 1 year
description: Initiation (time to initiation)
measure: Time to discontinuation
time frame: 5 years
description: Discontinuation (Time to discontinuation)
measure: Self reported Adherence to vitamin-and mineral supplementation
time frame: 5 years
description: Medication Adherence Report Scale (MARS-5) score 1-25, higher scores mean a better outcome
measure: Hemoglobin (Hb)
time frame: 5 years
description: g/L
measure: Iron status
time frame: 5 years
description: µmol/L
measure: s-folate
time frame: 5 years
description: nmol/L
measure: p-calcium
time frame: 5 years
description: mmol/L
measure: s-albumin
time frame: 5 years
description: g/L
measure: s-cobolamin
time frame: 5 years
description: pmol/L
intervention type: Procedure
intervention name: Gastric Bypass, Sleeve Gastrectomy
description: Lifelong vitamin and Mineral supplementation
other name: Vitamin and Mineral supplementation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ellen Andersson
role: Principal Investigator
affiliation: Region Östergötland
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Region Östergötland
investigator full name: Ellen Andersson
investigator title: MD, PhD, Consultant Upper GI Surgeon
mesh term: Vitamins
sharing ipd: No