<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/NCT01661309</url>
  </required_header>
  <id_info>
    <org_study_id>Methylcobalamin</org_study_id>
    <nct_id>NCT01661309</nct_id>
  </id_info>
  <brief_title>Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial</brief_title>
  <official_title>To Critically Investigate and Evaluate Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians, Who May Have a Resultant Susceptibility to Hyperhomocysteinemia Related Diseases.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of West London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of West London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary&#xD;
      animal produce, which can elevate homocysteine. There is strong evidence indicating that&#xD;
      elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as&#xD;
      primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant&#xD;
      decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin&#xD;
      B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of plasma total homocysteine of vegetarians</measure>
    <time_frame>16 weeks per participant</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in systolic and diastolic blood pressure</measure>
    <time_frame>16 weeks per participant</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Improvement in body mass index</measure>
    <time_frame>16 weeks per participant</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Vitamin B12 Deficiency</condition>
  <arm_group>
    <arm_group_label>Inactive lozenge</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Inactive lozenge containing 2mg sucrose dissolved in the mouth taken after a meal every other day for 16 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Methylcobalamin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Methylcobalamin 1mg lozenge dissolved in the mouth following a meal taken every other day for 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Inactive lozenge</intervention_name>
    <description>Manufactured to mimic 1mg methylcobalamin lozenge</description>
    <arm_group_label>Inactive lozenge</arm_group_label>
    <arm_group_label>Methylcobalamin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Methylcobalamin</intervention_name>
    <description>Aimed at reducing plasma tHcy.</description>
    <arm_group_label>Inactive lozenge</arm_group_label>
    <arm_group_label>Methylcobalamin</arm_group_label>
    <other_name>Vitamin B12</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having a plasma tHcy &gt;10 micromol/L&#xD;
&#xD;
          -  Not suffering from conditions as described in exclusion criteria.&#xD;
&#xD;
          -  Vegetarian for at least one year.&#xD;
&#xD;
          -  Not participating in a weight reducing diet.&#xD;
&#xD;
          -  Not consuming regularly vitamin B12 supplements.&#xD;
&#xD;
          -  Give written consent to participate in clinical trial and be fluent in English&#xD;
             language.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a plasma tHcy less or equal to 10 micromol/L.&#xD;
&#xD;
          -  Suffering from pernicious anemia or other vitamin B12 deficiency disease.&#xD;
&#xD;
          -  Undergone bowel surgery or suffer from gastrointestinal disease.&#xD;
&#xD;
          -  Pregnant, lactating or trying to conceive.&#xD;
&#xD;
          -  Smoker.&#xD;
&#xD;
          -  Alcohol intake regularly greater than official recommended daily units (i.e. 2 units&#xD;
             female, 3 units male).&#xD;
&#xD;
          -  Consume large amounts of caffeine (regular consumption of &gt;4 cups of strong tea or&#xD;
             coffee per day).&#xD;
&#xD;
          -  Use of medications known to influence nutritional status.&#xD;
&#xD;
          -  Have genetic metabolic disease.&#xD;
&#xD;
          -  Suffer from renal failure, diabetes, thyroid disease, cardiovascular disease, dementia&#xD;
             or cancer.&#xD;
&#xD;
          -  Have a known blood-borne infection (e.g. Hepatitis or HIV).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amalia A Tsiami, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of West London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David C Chappell, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of West London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of West London</name>
      <address>
        <city>London</city>
        <state>Middlesex</state>
        <zip>TW8 9GA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>May 18, 2014</last_update_submitted>
  <last_update_submitted_qc>May 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of West London</investigator_affiliation>
    <investigator_full_name>Derek Obersby</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <keyword>Hyperhomocysteinemia</keyword>
  <keyword>Methylcobalamin</keyword>
  <keyword>Cardiovascular disease</keyword>
  <keyword>Plasma total homocysteine</keyword>
  <keyword>Vegetarians</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperhomocysteinemia</mesh_term>
    <mesh_term>Vitamin B 12 Deficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin B 12</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/NCT01661309
org study id: Methylcobalamin
nct id: NCT01661309
lead sponsor: 
has dmc: Yes
Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary
      animal produce, which can elevate homocysteine. There is strong evidence indicating that
      elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as
      primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant
      decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin
      B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Reduction of plasma total homocysteine of vegetarians
time frame: 16 weeks per participant
measure: Improvement in systolic and diastolic blood pressure
time frame: 16 weeks per participant
measure: Improvement in body mass index
time frame: 16 weeks per participant
arm group label: Inactive lozenge
arm group type: Placebo Comparator
description: Inactive lozenge containing 2mg sucrose dissolved in the mouth taken after a meal every other day for 16 weeks
arm group label: Methylcobalamin
arm group type: Experimental
description: Methylcobalamin 1mg lozenge dissolved in the mouth following a meal taken every other day for 16 weeks.
intervention type: Dietary Supplement
intervention name: Inactive lozenge
description: Manufactured to mimic 1mg methylcobalamin lozenge
arm group label: Inactive lozenge
arm group label: Methylcobalamin
intervention type: Dietary Supplement
intervention name: Methylcobalamin
description: Aimed at reducing plasma tHcy.
arm group label: Inactive lozenge
arm group label: Methylcobalamin
other name: Vitamin B12
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amalia A Tsiami, PhD
role: Study Director
affiliation: University of West London
last name: David C Chappell, PhD
role: Study Director
affiliation: University of West London
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of West London
investigator full name: Derek Obersby
investigator title: PhD Student
mesh term: Hyperhomocysteinemia
mesh term: Vitamin B 12 Deficiency
mesh term: Vitamin B 12