<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/NCT01691365</url>
  </required_header>
  <id_info>
    <org_study_id>FMHS</org_study_id>
    <nct_id>NCT01691365</nct_id>
  </id_info>
  <brief_title>Effects of Antioxidants and B Vitamins Supplements on Inflammation in Obese Diabetic Patients</brief_title>
  <official_title>Oxidative Damage and Inflammation in Obese Diabetic Emirati Subjects Supplemented With Antioxidants and B-vitamins: a Randomized Placebo-controlled Trail</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United Arab Emirates University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tawam Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>United Arab Emirates University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Substantial evidence shows that diets incorporating antioxidants and B-group vitamins can&#xD;
      offer significant protection against infections and cardiovascular disease (CVD) especially&#xD;
      in diabetic patients. The proposed study will determine whether improvements in antioxidants&#xD;
      and B-group vitamins in diabetic patients who are known to have a high risk of CVD will lead&#xD;
      to a clinical benefit&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following informed written consent 96 diabetic patients will be randomly assigned to receive&#xD;
      either an oral dose of daily B-group vitamins (5 mg folic acid, 5mg vitamin B-2, 50 mg&#xD;
      vitamin B-6, 0.4 mg vitamin B-12) and antioxidant vitamins [800 IU (727mg) of a-tocopherol&#xD;
      and 500mg of vitamin C] [n=48], or no supplements [n= 48] daily for 90 days. All subjects&#xD;
      will have three assessments, at baseline, 3, and 12 months post-randomisation. The assessment&#xD;
      will include markers of inflammation, endothelial dysfunction, oxidative stress,&#xD;
      antioxidants, total plasma homocysteine and risk of infections. A fasting 15-ml of blood will&#xD;
      be taken for measurements of total plasma homocysteine concentration, markers of&#xD;
      inflammation, endothelial dysfunction, oxidative damage and vitamin concentrations. Further&#xD;
      information on clinical variables which may influence endothelial dysfunction, antioxidant&#xD;
      capacity, immunity and diabetes control status will be collected and adjusted for during&#xD;
      analysis.&#xD;
&#xD;
      Potential Significance- the study will help to clarify the temporal relationships between ,&#xD;
      markers of inflammation, endothelial dysfunction and oxidative stress and risk of infections&#xD;
      and form the basis of appropriate intervention strategies to minimise the long-term&#xD;
      complications associated with type 2 diabetes mellitus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">December 2009</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inflammation</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxidative damage</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antioxidant status</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Infections</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Diabetes</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>vitamins pills</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>antioxidant and B vitamins vitamins vitamin&#xD;
--------------------------------------------------------------------------------</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pills</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>MICROCRYSTALLINE CELLULOSE</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>vitamins</intervention_name>
    <description>a capsule of antioxidant vitamins 221mg of alpha tocopherol and 167mg of vitamin C and B-group vitamins (1.67 mg folic acid, 1.67mg vitamin B-2, 20 mg vitamin B-6, 0.134 mg vitamin B-12) or an identical placebo daily for 90 days</description>
    <arm_group_label>vitamins pills</arm_group_label>
    <other_name>Antioxidants</other_name>
    <other_name>B vitamins</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo Capsule shell (Hydroxypropylmethyl cellulose, Hydroxypropylcellulose, Propylene glycol as stabilizer, Colour-Titanium dioxide)</description>
    <arm_group_label>pills</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 Diabetes mellitus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe chronic clinical or psychiatric disease,&#xD;
&#xD;
          -  participating in other intervention trials,&#xD;
&#xD;
          -  on dietary supplements and&#xD;
&#xD;
          -  those unable to give an informed written consent&#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>Salah Gariballa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>United Arab Emirates University</affiliation>
  </overall_official>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>September 19, 2012</last_update_submitted>
  <last_update_submitted_qc>September 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>United Arab Emirates University</investigator_affiliation>
    <investigator_full_name>Salah Gariballa</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Antioxidant</keyword>
  <keyword>vitamins</keyword>
  <keyword>Diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Vitamin B Complex</mesh_term>
    <mesh_term>Antioxidants</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/NCT01691365
org study id: FMHS
nct id: NCT01691365
lead sponsor: 
collaborator: 
has dmc: No
Substantial evidence shows that diets incorporating antioxidants and B-group vitamins can
      offer significant protection against infections and cardiovascular disease (CVD) especially
      in diabetic patients. The proposed study will determine whether improvements in antioxidants
      and B-group vitamins in diabetic patients who are known to have a high risk of CVD will lead
      to a clinical benefit
Following informed written consent 96 diabetic patients will be randomly assigned to receive
      either an oral dose of daily B-group vitamins (5 mg folic acid, 5mg vitamin B-2, 50 mg
      vitamin B-6, 0.4 mg vitamin B-12) and antioxidant vitamins [800 IU (727mg) of a-tocopherol
      and 500mg of vitamin C] [n=48], or no supplements [n= 48] daily for 90 days. All subjects
      will have three assessments, at baseline, 3, and 12 months post-randomisation. The assessment
      will include markers of inflammation, endothelial dysfunction, oxidative stress,
      antioxidants, total plasma homocysteine and risk of infections. A fasting 15-ml of blood will
      be taken for measurements of total plasma homocysteine concentration, markers of
      inflammation, endothelial dysfunction, oxidative damage and vitamin concentrations. Further
      information on clinical variables which may influence endothelial dysfunction, antioxidant
      capacity, immunity and diabetes control status will be collected and adjusted for during
      analysis.

      Potential Significance- the study will help to clarify the temporal relationships between ,
      markers of inflammation, endothelial dysfunction and oxidative stress and risk of infections
      and form the basis of appropriate intervention strategies to minimise the long-term
      complications associated with type 2 diabetes mellitus.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Inflammation
time frame: 3 months
measure: Oxidative damage
time frame: 3 months
measure: Antioxidant status
time frame: 3 months
measure: Infections
time frame: 12 months
arm group label: vitamins pills
arm group type: Active Comparator
description: antioxidant and B vitamins vitamins vitamin
--------------------------------------------------------------------------------
arm group label: pills
arm group type: Placebo Comparator
description: MICROCRYSTALLINE CELLULOSE
intervention type: Dietary Supplement
intervention name: vitamins
description: a capsule of antioxidant vitamins 221mg of alpha tocopherol and 167mg of vitamin C and B-group vitamins (1.67 mg folic acid, 1.67mg vitamin B-2, 20 mg vitamin B-6, 0.134 mg vitamin B-12) or an identical placebo daily for 90 days
arm group label: vitamins pills
other name: Antioxidants
other name: B vitamins
intervention type: Drug
intervention name: Placebo
description: Placebo Capsule shell (Hydroxypropylmethyl cellulose, Hydroxypropylcellulose, Propylene glycol as stabilizer, Colour-Titanium dioxide)
arm group label: pills
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Salah Gariballa, MD
role: Principal Investigator
affiliation: United Arab Emirates University
responsible party type: Principal Investigator
investigator affiliation: United Arab Emirates University
investigator full name: Salah Gariballa
investigator title: Professor
mesh term: Inflammation
mesh term: Vitamins
mesh term: Vitamin B Complex
mesh term: Antioxidants