<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/NCT02222649</url>
  </required_header>
  <id_info>
    <org_study_id>IGabriela</org_study_id>
    <secondary_id>0374/12</secondary_id>
    <nct_id>NCT02222649</nct_id>
  </id_info>
  <brief_title>Evaluation of the High Dose Vitamin D3 Supplementation Effect and Influence of Polymorphism VDR Gene on Oxidative Stress and Inflammatory Process in Elderly</brief_title>
  <official_title>EVALUATION OF THE HIGH DOSE VITAMIN D3 SUPPLEMENTATION EFFECT AND INFLUENCE OF POLYMORPHISM VDR GENE ON OXIDATIVE STRESS AND INFLAMMATORY PROCESS IN ELDERLY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Paraíba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Paraíba</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A vitamin D3 high dose would act as an antioxidant and anti-inflammatory improving markers of&#xD;
      oxidative stress and inflammation in the elderly. Seniors exhibiting polymorphism in the VDR&#xD;
      gene would become non-responsive to supplementation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The high prevalence of hypovitaminosis D in the elderly can be identified as a risk factor&#xD;
      for developing cardiovascular disease and consequent increase in oxidative stress and chronic&#xD;
      inflammation. Polymorphisms in the gene that encodes the vitamin D receptor (VDR) can&#xD;
      influence the cellular responses supplementation of vitamin D. The study objective is to&#xD;
      evaluate the influence of supplementation of 200,000 in a single high dose of vitamin D3 in&#xD;
      the inflammatory status and oxidative stress elderly and the influence of polymorphism of the&#xD;
      VDR gene in this response. One randomized, placebo-controlled clinical trial, designed with&#xD;
      non-institutionalized elderly in northeastern Brazil will be held. All volunteers will sign&#xD;
      the Instrument of Consent and will undergo clinical, nutritional, anthropometric and&#xD;
      biochemical evaluation. The purpose is to produce new knowledge helping to unravel the&#xD;
      beneficial effects of vitamin D3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of elderly women with sufficient vitamin D levels</measure>
    <time_frame>four weeks after the intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of elderly who have reduced serum levels of High-Sensitivity C-Reactive Protein</measure>
    <time_frame>four weeks after the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of elderly who have reduced serum levels of Alpha 1 Acid Glycoprotein</measure>
    <time_frame>four weeks after the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of elderly who have reduced plasma levels of malondialdehyde (MDA)</measure>
    <time_frame>four weeks after the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of elderly that increased plasma antioxidant full capacity</measure>
    <time_frame>four weeks after the intervention</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants with Polymorphism of the VDR gene</measure>
    <time_frame>Participants will be followed for the duration of recruitment , an expected average of 1 week</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Disorder of Aging</condition>
  <arm_group>
    <arm_group_label>Vitamin D3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group supplemented with high single dose of 200,000 IU of vitamin D3 (cholecalciferol)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules with starch</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <description>High dose of 200,000 IU of cholecalciferol orally in a single dose</description>
    <arm_group_label>Vitamin D3</arm_group_label>
    <other_name>cholecalciferol</other_name>
    <other_name>High dose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Capsules of starch, no therapeutic action</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 60 years; diagnosis of failure / vitamin D, preserved cognitive status,&#xD;
             disability accepting participate and are not included in any of the exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  excluded from the study in the elderly using vitamin D supplements; anticonvulsant&#xD;
             drugs or for the treatment of HIV / AIDS; diagnosis of type I diabetes mellitus,&#xD;
             nephrotic syndrome, acute or chronic renal failure, liver disease, hypothyroidism,&#xD;
             hyperthyroidism, history of cerebrovascular accident (CVA) or acute myocardial&#xD;
             infarction (AMI) Vascular past 6 months and chronic consumptive diseases, alcoholic or&#xD;
             smoker chronic.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isa Gabriela M Cavalcante, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Paraíba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria da Conceição R Gonçalves, PDH</last_name>
    <role>Study Director</role>
    <affiliation>Federal University of Paraíba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alexandre S Silva, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Federal University of Paraíba</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Isa Gabriela M Cavalcante, DDS</last_name>
    <phone>+55 (83) 9112 0584</phone>
    <email>isa.gabriela@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Program for Attention to Elderly, belonging to the Municipality of João Pessoa</name>
      <address>
        <city>João Pessoa</city>
        <state>Paraíba</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isa Gabriela M Cavalcante, DDS</last_name>
      <phone>+55 (83) 9112 0584</phone>
      <email>isa.gabriela@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>DDS</last_name>
    </contact_backup>
    <investigator>
      <last_name>Isa Gabriela M Cavalcante, DDS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>March 4, 2015</last_update_submitted>
  <last_update_submitted_qc>March 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Paraíba</investigator_affiliation>
    <investigator_full_name>Isa G M Cavalcante, DDS</investigator_full_name>
    <investigator_title>Master student</investigator_title>
  </responsible_party>
  <keyword>Elderly</keyword>
  <keyword>vitamin D insufficiency</keyword>
  <keyword>High dose vitamin D3 supplementation</keyword>
  <keyword>Polymorphism of the VDR gene</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Cholecalciferol</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/NCT02222649
org study id: IGabriela
secondary id: 0374/12
nct id: NCT02222649
lead sponsor: 
has dmc: Yes
A vitamin D3 high dose would act as an antioxidant and anti-inflammatory improving markers of
      oxidative stress and inflammation in the elderly. Seniors exhibiting polymorphism in the VDR
      gene would become non-responsive to supplementation.
The high prevalence of hypovitaminosis D in the elderly can be identified as a risk factor
      for developing cardiovascular disease and consequent increase in oxidative stress and chronic
      inflammation. Polymorphisms in the gene that encodes the vitamin D receptor (VDR) can
      influence the cellular responses supplementation of vitamin D. The study objective is to
      evaluate the influence of supplementation of 200,000 in a single high dose of vitamin D3 in
      the inflammatory status and oxidative stress elderly and the influence of polymorphism of the
      VDR gene in this response. One randomized, placebo-controlled clinical trial, designed with
      non-institutionalized elderly in northeastern Brazil will be held. All volunteers will sign
      the Instrument of Consent and will undergo clinical, nutritional, anthropometric and
      biochemical evaluation. The purpose is to produce new knowledge helping to unravel the
      beneficial effects of vitamin D3.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: number of elderly women with sufficient vitamin D levels
time frame: four weeks after the intervention
measure: number of elderly who have reduced serum levels of High-Sensitivity C-Reactive Protein
time frame: four weeks after the intervention
measure: number of elderly who have reduced serum levels of Alpha 1 Acid Glycoprotein
time frame: four weeks after the intervention
measure: number of elderly who have reduced plasma levels of malondialdehyde (MDA)
time frame: four weeks after the intervention
measure: number of elderly that increased plasma antioxidant full capacity
time frame: four weeks after the intervention
measure: Number of Participants with Polymorphism of the VDR gene
time frame: Participants will be followed for the duration of recruitment , an expected average of 1 week
arm group label: Vitamin D3
arm group type: Experimental
description: Group supplemented with high single dose of 200,000 IU of vitamin D3 (cholecalciferol)
arm group label: placebo group
arm group type: Placebo Comparator
description: Placebo capsules with starch
intervention type: Dietary Supplement
intervention name: Vitamin D3
description: High dose of 200,000 IU of cholecalciferol orally in a single dose
arm group label: Vitamin D3
other name: cholecalciferol
other name: High dose
intervention type: Dietary Supplement
intervention name: Placebo
description: Capsules of starch, no therapeutic action
arm group label: placebo group
criteria: 
gender: Female
minimum age: 60 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Isa Gabriela M Cavalcante, DDS
role: Principal Investigator
affiliation: Federal University of Paraíba
last name: Maria da Conceição R Gonçalves, PDH
role: Study Director
affiliation: Federal University of Paraíba
last name: Alexandre S Silva, PHD
role: Study Director
affiliation: Federal University of Paraíba
last name: Isa Gabriela M Cavalcante, DDS
phone: +55 (83) 9112 0584
email: isa.gabriela@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Paraíba
investigator full name: Isa G M Cavalcante, DDS
investigator title: Master student
mesh term: Vitamin D
mesh term: Cholecalciferol