<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/NCT03292744</url>
  </required_header>
  <id_info>
    <org_study_id>VitaminDIndonesia</org_study_id>
    <nct_id>NCT03292744</nct_id>
  </id_info>
  <brief_title>Effect of Alfacalcidol to Respiratory Infection and Immune Response of Indonesian Elderly</brief_title>
  <official_title>Effect of Alfacalcidol Supplementation to Respiratory Infection, Inflammatory Markers and CD4/CD8 Ratio of Indonesian Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indonesia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</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>
      Vitamin D has been known to influence immune response through Vitamin D Receptor in Immune&#xD;
      Cells, but only few has been known about the effect alfacalcidol, a vitamin D analog to&#xD;
      immune system. In elderly, immune disregulation or immunosenecence have great impact to&#xD;
      infection response. This study is aimed to determine the effect of alfacalcidol&#xD;
      supplementation in vitro and in vivo to respiratory infection incidence and inflammatory&#xD;
      markers, as well as T cell lymphocyte subset in Indonesian elderly patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consist of 2 designs. First is in vitro study to investigate the effect of&#xD;
      alfacalcidol supplementation to IL-6, IL-10 and IFN gamma regulation in Peripheral Blood&#xD;
      Mononuclear Cells (PBMC) of elderly and second design is randomised controlled trial to&#xD;
      evaluate the effect of 3 months supplementation of alfacalcidol 0,5 mcg in respiratory&#xD;
      infection, antibiotic use, inflammatory markers, CD4/CD8 ratio and CD8+ CD28+ in Indonesian&#xD;
      elderly with various level of frailty syndrome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 10, 2017</start_date>
  <completion_date type="Anticipated">December 15, 2017</completion_date>
  <primary_completion_date type="Anticipated">October 10, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>upper respiratory tract infection incidence</measure>
    <time_frame>90 days</time_frame>
    <description>incidence of URTI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>lower respiratory tract infection incidence</measure>
    <time_frame>90 days</time_frame>
    <description>incidence of LRTI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>inflammatory markers</measure>
    <time_frame>day 90</time_frame>
    <description>IL6, IL10 and IFN gamma in PBMC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T cell subset</measure>
    <time_frame>day 90</time_frame>
    <description>CD4/CD8 ratio, CD8+ CD28- percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>antibiotic use</measure>
    <time_frame>90 days</time_frame>
    <description>any antibiotic prescribed by physician</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Frail Elderly Syndrome</condition>
  <condition>Elderly Infection</condition>
  <arm_group>
    <arm_group_label>Alfacalcidol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alfacalcidol 0,5 mcg once daily for 90 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Amylum same capsule form, weight and colour with treatment arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alfacalcidol</intervention_name>
    <description>alfacalcidol 0,5 mcg</description>
    <arm_group_label>Alfacalcidol</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>1 alpha hydroxy cholecalciferol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elderly age more than 60&#xD;
&#xD;
          -  Willing to join research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In acute infection&#xD;
&#xD;
          -  Using NSAID or steroid&#xD;
&#xD;
          -  Liver failure&#xD;
&#xD;
          -  Hypercalcemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aulia Rizka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitas Indonesia / Cipto Mangunkusumo Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aulia Rizka, MD</last_name>
    <phone>+628125265600</phone>
    <email>dr.auliarizka@yahoo.co.id</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aulia Rizka, MD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cipto Mangunkusumo National Hospital</name>
      <address>
        <city>Jakarta</city>
        <country>Indonesia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aulia Rizka, MD</last_name>
      <phone>+628125265600</phone>
      <email>dr.auliarizka@yahoo.co.id</email>
    </contact>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 21, 2017</last_update_submitted>
  <last_update_submitted_qc>September 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>Aulia Rizka</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>immunosenescence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Alfacalcidol</mesh_term>
    <mesh_term>Hydroxycholecalciferols</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/NCT03292744
org study id: VitaminDIndonesia
nct id: NCT03292744
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Vitamin D has been known to influence immune response through Vitamin D Receptor in Immune
      Cells, but only few has been known about the effect alfacalcidol, a vitamin D analog to
      immune system. In elderly, immune disregulation or immunosenecence have great impact to
      infection response. This study is aimed to determine the effect of alfacalcidol
      supplementation in vitro and in vivo to respiratory infection incidence and inflammatory
      markers, as well as T cell lymphocyte subset in Indonesian elderly patients.
This study consist of 2 designs. First is in vitro study to investigate the effect of
      alfacalcidol supplementation to IL-6, IL-10 and IFN gamma regulation in Peripheral Blood
      Mononuclear Cells (PBMC) of elderly and second design is randomised controlled trial to
      evaluate the effect of 3 months supplementation of alfacalcidol 0,5 mcg in respiratory
      infection, antibiotic use, inflammatory markers, CD4/CD8 ratio and CD8+ CD28+ in Indonesian
      elderly with various level of frailty syndrome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: upper respiratory tract infection incidence
time frame: 90 days
description: incidence of URTI
measure: lower respiratory tract infection incidence
time frame: 90 days
description: incidence of LRTI
measure: inflammatory markers
time frame: day 90
description: IL6, IL10 and IFN gamma in PBMC
measure: T cell subset
time frame: day 90
description: CD4/CD8 ratio, CD8+ CD28- percentage
measure: antibiotic use
time frame: 90 days
description: any antibiotic prescribed by physician
arm group label: Alfacalcidol
arm group type: Experimental
description: Alfacalcidol 0,5 mcg once daily for 90 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Amylum same capsule form, weight and colour with treatment arm
intervention type: Drug
intervention name: Alfacalcidol
description: alfacalcidol 0,5 mcg
arm group label: Alfacalcidol
arm group label: Placebo
other name: 1 alpha hydroxy cholecalciferol
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aulia Rizka, MD
role: Principal Investigator
affiliation: Universitas Indonesia / Cipto Mangunkusumo Hospital
last name: Aulia Rizka, MD
phone: +628125265600
email: dr.auliarizka@yahoo.co.id
last name: Aulia Rizka, MD
facility: 
status: Recruiting
contact: 
country: Indonesia
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: Aulia Rizka
investigator title: MD
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
mesh term: Cholecalciferol
mesh term: Alfacalcidol
mesh term: Hydroxycholecalciferols
sharing ipd: No