<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/NCT01731340</url>
  </required_header>
  <id_info>
    <org_study_id>GEN-11-231</org_study_id>
    <nct_id>NCT01731340</nct_id>
  </id_info>
  <brief_title>A Study on the Impact of Calcium on Woman's Vascular Health</brief_title>
  <official_title>The Effect of Dietary Calcium Intake as Compared to Calcium Supplementation on Vascular Health and Bone Health in Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overarching aim of this randomized clinical trial is to estimate the effect of dietary&#xD;
      intake of calcium as compared to supplemental calcium on the vascular system and markers of&#xD;
      vascular and bone health in postmenopausal women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Calcium and vitamin D are essential nutrients for optimal bone health throughout life.&#xD;
      Research has shown that postmenopausal women who consume appropriate amounts of these&#xD;
      nutrients have better bone strength and fewer fractures than those who don't. However,&#xD;
      researchers have recently questioned the safety of calcium and vitamin D obtained through&#xD;
      supplements as they might increase the risk of cardiovascular events such as heart attacks&#xD;
      and strokes.&#xD;
&#xD;
      The investigators propose to estimate the effect of dietary intake of calcium as compared to&#xD;
      supplemental calcium on vascular and bone health in postmenopausal women.&#xD;
&#xD;
      Eligible participants will be assigned by chance (like a coin toss) to one of three groups:&#xD;
      (1) 1200 mg of calcium from dietary sources and 1 capsule of 400 IU vitamin D supplement&#xD;
      everyday after the first meal of the day; (2) 450 mg of calcium from dietary sources, 2&#xD;
      tablets of 250 mg calcium citrate supplement and 1 capsule of 800 IU vitamin D supplement&#xD;
      everyday after the first meal of the day and 1 tablet of 250 mg calcium citrate supplement&#xD;
      after the evening meal or snack; or (3) unrestricted calcium from dietary sources and 1&#xD;
      capsule of 400 IU vitamin D supplement everyday after the first meal of the day. Participants&#xD;
      have an equal chance of being assigned to any of these three groups until 26 participants&#xD;
      have been assigned to group (3). At this time participants will continue to be assigned by&#xD;
      chance to either of the two remaining groups only.&#xD;
&#xD;
      Participants will also attend appointments at the Montreal General Hospital every 6-months&#xD;
      where they will undergo anthropometric measurements, blood tests, urine tests, non-invasive&#xD;
      ultrasounds to measure arterial stiffness and questionnaires. The questionnaires ask about&#xD;
      health; lifestyle habits such as physical exercise, diet, and smoking; use of medications and&#xD;
      dietary supplements; family history of illness, and past medical diagnoses. Participants will&#xD;
      also receive monthly phone calls from study staff to monitor for adverse events and&#xD;
      adherence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2012</start_date>
  <completion_date type="Actual">November 14, 2018</completion_date>
  <primary_completion_date type="Actual">November 14, 2018</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vascular System</measure>
    <time_frame>12 months</time_frame>
    <description>Measured as changes in:&#xD;
Arterial stiffness (carotid-femoral pulse wave velocity)&#xD;
Arterial wall thickness (carotid intima-media thickness)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemodynamics</measure>
    <time_frame>12 Months</time_frame>
    <description>Measured as changes in:&#xD;
- Peripheral blood pressure</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Blood Biomarkers</measure>
    <time_frame>12 months</time_frame>
    <description>Measured as changes in:&#xD;
Vascular health biomarkers&#xD;
Bone health biomarkers</description>
  </other_outcome>
  <other_outcome>
    <measure>Anthropomorphic measurements</measure>
    <time_frame>12 months</time_frame>
    <description>Measured as changes in bone health biomarkers.&#xD;
Body mass index&#xD;
Waist circumference&#xD;
Body fat %</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>12 months</time_frame>
    <description>Occurrence of cardiovascular, cerebrovascular and renal events as well as fractures and intolerance to interventions.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Supplemental Calcium</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>750 mg Calcium Citrate per day&#xD;
800 IU Vitamin D3 per day&#xD;
Low Dietary Calcium (450 mg per day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dietary Calcium</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>400 IU Vitamin D3 per day&#xD;
High Dietary Calcium (1200 mg per day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Diet</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>400 IU Vitamin D3 per day&#xD;
Unrestricted Dietary Calcium</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Calcium Citrate</intervention_name>
    <description>750mg</description>
    <arm_group_label>Supplemental Calcium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low Dietary Calcium</intervention_name>
    <description>450 mg</description>
    <arm_group_label>Supplemental Calcium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Dietary Calcium</intervention_name>
    <description>1200 mg</description>
    <arm_group_label>Dietary Calcium</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 50 or more&#xD;
&#xD;
          -  2 years since last menstrual period&#xD;
&#xD;
          -  Body Mass Index between 20 and 35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atrial Fibrillation&#xD;
&#xD;
          -  Coronary artery disease&#xD;
&#xD;
          -  Myocardial infarction&#xD;
&#xD;
          -  Stroke&#xD;
&#xD;
          -  Transient ischaemic attack&#xD;
&#xD;
          -  Peripheral vascular disease&#xD;
&#xD;
          -  Sleep apnea&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Hyperlipidemia&#xD;
&#xD;
          -  Hyperparathyroidism&#xD;
&#xD;
          -  Urinary tract lithiasis&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Crohn's disease&#xD;
&#xD;
          -  Ulcerative colitis&#xD;
&#xD;
          -  Short gut syndrome&#xD;
&#xD;
          -  Celiac disease&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Cancer (any other than basal cell cancer of the skin)&#xD;
&#xD;
          -  Pre-eclampsia&#xD;
&#xD;
          -  Smoked in the last 5 years&#xD;
&#xD;
          -  Cocaine use in the last year&#xD;
&#xD;
          -  Consumption of more than 9 alcoholic drinks per week&#xD;
&#xD;
          -  Chronic NSAID use&#xD;
&#xD;
          -  Use of oral glucocorticoids or HRT (excluding vaginal preparations) in the last 2&#xD;
             years&#xD;
&#xD;
          -  Use of anti-osteoporosis medications (bisphosphonates, selective estrogen-receptor&#xD;
             modulators, denosumab, teriparatide, or calcitonin) in the last 3 years or&#xD;
             anti-osteoporosis therapy which ended more than 3 years ago and whose duration was ≥ 5&#xD;
             years, or a fracture of the spine, shoulder, or hip was sustained while therapy&#xD;
&#xD;
          -  Use of calcium and vitamin D supplements (including multivitamins and&#xD;
             calcium-containing antacids) in the last 2 months&#xD;
&#xD;
          -  High 10-year probability of major osteoporotic fracture (FRAX without BMD &gt; 20%)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzanne Morin, MD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University Hospital Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Internal Medicine; Montreal General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3G 1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>September 16, 2019</last_update_submitted>
  <last_update_submitted_qc>September 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Suzanne Morin</investigator_full_name>
    <investigator_title>MD MSc FRCP</investigator_title>
  </responsible_party>
  <keyword>Calcium Supplements</keyword>
  <keyword>Dairy Foods</keyword>
  <keyword>Cardiovascular Diseases</keyword>
  <keyword>Osteoporosis</keyword>
  <keyword>Postmenopause</keyword>
  <keyword>Vitamin D</keyword>
  <keyword>Micronutrients</keyword>
  <keyword>Primary Prevention</keyword>
  <keyword>Bone Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Calcium</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/NCT01731340
org study id: GEN-11-231
nct id: NCT01731340
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overarching aim of this randomized clinical trial is to estimate the effect of dietary
      intake of calcium as compared to supplemental calcium on the vascular system and markers of
      vascular and bone health in postmenopausal women.
Calcium and vitamin D are essential nutrients for optimal bone health throughout life.
      Research has shown that postmenopausal women who consume appropriate amounts of these
      nutrients have better bone strength and fewer fractures than those who don't. However,
      researchers have recently questioned the safety of calcium and vitamin D obtained through
      supplements as they might increase the risk of cardiovascular events such as heart attacks
      and strokes.

      The investigators propose to estimate the effect of dietary intake of calcium as compared to
      supplemental calcium on vascular and bone health in postmenopausal women.

      Eligible participants will be assigned by chance (like a coin toss) to one of three groups:
      (1) 1200 mg of calcium from dietary sources and 1 capsule of 400 IU vitamin D supplement
      everyday after the first meal of the day; (2) 450 mg of calcium from dietary sources, 2
      tablets of 250 mg calcium citrate supplement and 1 capsule of 800 IU vitamin D supplement
      everyday after the first meal of the day and 1 tablet of 250 mg calcium citrate supplement
      after the evening meal or snack; or (3) unrestricted calcium from dietary sources and 1
      capsule of 400 IU vitamin D supplement everyday after the first meal of the day. Participants
      have an equal chance of being assigned to any of these three groups until 26 participants
      have been assigned to group (3). At this time participants will continue to be assigned by
      chance to either of the two remaining groups only.

      Participants will also attend appointments at the Montreal General Hospital every 6-months
      where they will undergo anthropometric measurements, blood tests, urine tests, non-invasive
      ultrasounds to measure arterial stiffness and questionnaires. The questionnaires ask about
      health; lifestyle habits such as physical exercise, diet, and smoking; use of medications and
      dietary supplements; family history of illness, and past medical diagnoses. Participants will
      also receive monthly phone calls from study staff to monitor for adverse events and
      adherence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Vascular System
time frame: 12 months
description: Measured as changes in:
Arterial stiffness (carotid-femoral pulse wave velocity)
Arterial wall thickness (carotid intima-media thickness)
measure: Hemodynamics
time frame: 12 Months
description: Measured as changes in:
- Peripheral blood pressure
measure: Blood Biomarkers
time frame: 12 months
description: Measured as changes in:
Vascular health biomarkers
Bone health biomarkers
measure: Anthropomorphic measurements
time frame: 12 months
description: Measured as changes in bone health biomarkers.
Body mass index
Waist circumference
Body fat %
measure: Adverse Events
time frame: 12 months
description: Occurrence of cardiovascular, cerebrovascular and renal events as well as fractures and intolerance to interventions.
arm group label: Supplemental Calcium
arm group type: Active Comparator
description: 750 mg Calcium Citrate per day
800 IU Vitamin D3 per day
Low Dietary Calcium (450 mg per day)
arm group label: Dietary Calcium
arm group type: Active Comparator
description: 400 IU Vitamin D3 per day
High Dietary Calcium (1200 mg per day)
arm group label: Usual Diet
arm group type: No Intervention
description: 400 IU Vitamin D3 per day
Unrestricted Dietary Calcium
intervention type: Dietary Supplement
intervention name: Calcium Citrate
description: 750mg
arm group label: Supplemental Calcium
intervention type: Other
intervention name: Low Dietary Calcium
description: 450 mg
arm group label: Supplemental Calcium
intervention type: Other
intervention name: High Dietary Calcium
description: 1200 mg
arm group label: Dietary Calcium
criteria: 
gender: Female
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Suzanne Morin, MD MSc
role: Principal Investigator
affiliation: McGill University Hospital Center
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Suzanne Morin
investigator title: MD MSc FRCP
mesh term: Osteoporosis
mesh term: Cardiovascular Diseases
mesh term: Calcium, Dietary
mesh term: Calcium
sharing ipd: No