<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/NCT01726777</url>
  </required_header>
  <id_info>
    <org_study_id>UTRS-27546</org_study_id>
    <nct_id>NCT01726777</nct_id>
  </id_info>
  <brief_title>Effect of Vitamin D Supplementation on Glucose Tolerance in Subjects at Risk for Diabetes With Low Vitamin D.</brief_title>
  <acronym>EVIDENCE</acronym>
  <official_title>Effect of Vitamin D Supplementation on Oral Glucose Tolerance in Subjects Exhibiting Marginal Vitamin D Status and an Increased Risk of Developing Diabetes.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dairy Farmers of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Public Health Agency of Canada (PHAC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Type 2 diabetes (T2D) is an increasingly common and serious condition. Studies show that low&#xD;
      vitamin D levels are associated with increased diabetes risk and that vitamin D may protect&#xD;
      against diabetes by reducing chronic inflammation and improving insulin sensitivity and&#xD;
      insulin secretion. However, no studies have been able to show that vitamin D actually reduces&#xD;
      post-prandial blood glucose levels, the most clinically relevant marker of diabetes.&#xD;
      Previously the investigators have shown that cheddar cheese and low-fat cheese can be&#xD;
      fortified with high levels of vitamin D and that this cheese is at least as a effective as&#xD;
      vitamin D supplements in raising blood vitamin D levels.&#xD;
&#xD;
      The main purpose of this study is to see whether vitamin D enriched cheese can improve oral&#xD;
      glucose tolerance (reduce blood glucose 2 hours after consuming a drink containing 75g sugar)&#xD;
      in people who have low vitamin D levels and are at risk for developing T2D.&#xD;
&#xD;
      Other aims are to determine the effect of vitamin D may on insulin sensitivity, insulin&#xD;
      secretion, markers of inflammation, blood cholesterol levels, and safety markers such as&#xD;
      urinary calcium excretion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 2 diabetes (T2D) is an increasingly prevalent and serious condition whose risk appears&#xD;
      to be increased by low serum vitamin D concentrations. Epidemiological studies show an&#xD;
      association between increased diabetes risk and low serum vitamin D and studies suggest that&#xD;
      vitamin D may protect against diabetes by reducing chronic inflammation and improving insulin&#xD;
      sensitivity and insulin secretion. Although clinical studies show some of these effects, no&#xD;
      studies have been able to show that vitamin D supplementation reduces post-prandial blood&#xD;
      glucose, the most clinically relevant marker of diabetes and dysglycemia. Previously, the&#xD;
      investigators showed that cheddar cheese and low-fat cheese can be fortified with high levels&#xD;
      of vitamin D3 (28,000IU/ 30g portion) and that, in this form, it is at least as a effective&#xD;
      as vitamin D3 supplements in raising serum vitamin D concentrations. Since post-prandial&#xD;
      glucose is most sensitive to changes in insulin sensitivity the main purpose of this study is&#xD;
      to determine the effect of vitamin D supplementation on oral glucose tolerance (ie. serum&#xD;
      glucose 2h after 75g oral glucose) in individuals who are at risk for developing T2D.&#xD;
      Secondary objective are to determine the effect of vitamin D supplementation on insulin&#xD;
      sensitivity, insulin secretion, inflammatory markers, blood lipids and markers of safety&#xD;
      including serum parathyroid hormone levels and urinary calcium excretion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in plasma glucose concentration 2 hours after consuming 75g oral glucose (2 hour PC glucose, or 2hrPC glucose)</measure>
    <time_frame>24 Weeks</time_frame>
    <description>Change from baseline in plasma glucose concentration 2 hours after consuming 75g oral glucose.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in insulin resistance assessed using the homeostasis model assessment of insulin resistance (HOMA-IR)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in homeostasis model assessment of insulin resistance (HOMA-IR) which is G*I/22.5 where G is fasting plasma glucose (mmol/L) and I is fasting plasma insulin (uU/mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Matsuda insulin sensitivity index</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in Matsuda insulin sensitivity index which is (10,000/square root of [fasting glucose x fasting insulin] x [mean glucose x mean insulin during OGTT]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin secretion assessed using the homeostasis model assessment of beta-cell function (HOMA-B)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in homeostasis model assessment of beta-cell function (HOMA-B) which is 20*I/(G-3.5) where I is fasting plasma insulin (uU/mL) and G is fasting plasma glucose (mmol/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulinogenic index</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in insulinogenic index which is dI0-30/dG0-30, where dI0-30 is the change in plasma insulin between fasting and 30min and dG0-30 is the change in plasma glucose between fasting and 30min after 75g oral glucose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in disposition index derived from HOMA-IR and HOMA-B</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in disposition index which is HOMA-B/HOMA-IR, which have been defined above.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in disposition index based on oral glucose tolerance test (OGTT)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in ISSI-2 index which is AUCi/AUCg x Matsuda insulin sensitivity index, where AUCi and AUCg, respectively, are the total areas under the plasma insulin and glucose response curves after 75g oral glucose and Matsuda insulin sensitivity index has been defined above.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting plasma glucose</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in fasting plasma glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glucose area under the curve</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in incremental area under the glucose response curve after 75g oral glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glycated hemoglobin</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in glycated hemoglobin (HbA1c)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between changes in serum 25-hydroxy-vitamin D concentration (25(OH)D) and changes in 2 hour PC glucose</measure>
    <time_frame>24 weeks</time_frame>
    <description>Correlation between change from baseline in serum 25-hydroxy-vitamin D concentration and change from baseline in plasma glucose 2 hours after 75g oral glucose.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fasting serum 25(OH)D</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute concentration of serum 25-hydroxy-vitamin D3</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum 25(OH)D</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in serum 25-hydroxy-vitamin D3</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum total cholesterol</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in fasting serum total cholesterol</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum low-density lipoprotein (LDL) cholesterol</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in fasting serum calculated LDL cholesterol</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum high-density lipoprotein (HDL) cholesterol</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in fasting serum HDL cholesterol</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum triglycerides</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in fasting serum triglycerides</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum apolipoprotein B (apoB)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in fasting serum apolipoprotein B</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum c-reactive protein (CRP)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in fasting serum c-reactive protein</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum orosomucoid</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in fasting serum orosomucoid</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum haptoglobin</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in fasting serum haptoglobin</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum alpha-1-antitrypsin</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in fasting serum alpha-1-antitrypsin</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum aspartate aminotransferase (AST)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in fasting serum aspartate aminotransferase</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum alanine aminotransferase (ALT)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change from baseline in fasting serum alanine aminotransferase</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum calcium</measure>
    <time_frame>24 weeks</time_frame>
    <description>Absolute concentration of serum calcium</description>
  </other_outcome>
  <other_outcome>
    <measure>Urinary calcium:creatinine ratio</measure>
    <time_frame>24 weeks</time_frame>
    <description>Urinary calcium:creatinine ratio</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30g normal cheddar cheese once per week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30g cheddar cheese containing 28,000IU vitamin D once per week</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Normal cheddar cheese</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>Vitamin D3 supplemented cheddar cheese</description>
    <arm_group_label>Vitamin D</arm_group_label>
    <other_name>Vitamin D3</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or non-pregnant, non-lactating females, aged 18-75&#xD;
&#xD;
          -  volunteered to participate by signing the consent form&#xD;
&#xD;
          -  BMI &lt;40kg/ m2&#xD;
&#xD;
          -  vitamin D insufficient, defined as: serum 25(OH) vitamin D3 (25(OH)D) concentration&#xD;
             ≤65nmol/ L&#xD;
&#xD;
          -  increased risk for diabetes, defined as: FINDRISC score &gt;10 for Caucasians or &gt;6 for&#xD;
             non-Caucasians OR presence of metabolic syndrome&#xD;
&#xD;
          -  dysglycemia, defined as:fasting serum glucose 5.6 to 6.9 mmol/L, inclusive OR HbA1c&#xD;
             0.054 to 0.064, inclusive&#xD;
&#xD;
          -  systolic blood pressure ≤150/95 mmHg if not being treated for hypertension or ≤140/90&#xD;
             mmHg if on treatment for hypertension.&#xD;
&#xD;
          -  taking no prescription drugs, or stable (for at least 6 weeks) dose of birth control&#xD;
             pill, or drug(s) used to treat hypertension, hyperlipidemia, depression or other&#xD;
             mental illness or hypothyroid.&#xD;
&#xD;
          -  taking no supplements, or stable (for at least 6 weeks) dose of supplement(s).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects not meeting all inclusion criteria&#xD;
&#xD;
          -  history of renal failure or liver disease&#xD;
&#xD;
          -  serum creatinine &gt;1.8 times upper limit of normal (ULN)&#xD;
&#xD;
          -  serum aspartate or alanine transaminase (AST,ALT) &gt;3 times ULN&#xD;
&#xD;
          -  current use of drug or drugs to treat diabetes or use of steroids or pancreatic&#xD;
             enzymes&#xD;
&#xD;
          -  within 6 weeks of randomization, change in dose of supplements or drug(s) used to&#xD;
             treat hypertension, hyperlipidemia, depression or other mental illness or hypothyroid.&#xD;
&#xD;
          -  use of antibiotics within 3 months.&#xD;
&#xD;
          -  medical or surgical event requiring hospitalization within 3 months of randomization&#xD;
&#xD;
          -  presence of any condition affecting nutrient absorption&#xD;
&#xD;
          -  intolerance to cheese&#xD;
&#xD;
          -  plan to travel outside Canada for more than 14 consecutive days during the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas MS Wolever, DM, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Guelph</name>
      <address>
        <city>Guelph</city>
        <state>Ontario</state>
        <zip>N1G 2W1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glycemic Index Laboratories</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 2N8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de recherches cliniques de Montréal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2W 1R7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>September 15, 2015</last_update_submitted>
  <last_update_submitted_qc>September 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>Thomas Wolever</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Randomized controlled clinical trial</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Vitamin D</keyword>
  <keyword>Oral glucose tolerance</keyword>
  <keyword>Blood glucose</keyword>
  <keyword>Insulin resistance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</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/NCT01726777
org study id: UTRS-27546
nct id: NCT01726777
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Type 2 diabetes (T2D) is an increasingly common and serious condition. Studies show that low
      vitamin D levels are associated with increased diabetes risk and that vitamin D may protect
      against diabetes by reducing chronic inflammation and improving insulin sensitivity and
      insulin secretion. However, no studies have been able to show that vitamin D actually reduces
      post-prandial blood glucose levels, the most clinically relevant marker of diabetes.
      Previously the investigators have shown that cheddar cheese and low-fat cheese can be
      fortified with high levels of vitamin D and that this cheese is at least as a effective as
      vitamin D supplements in raising blood vitamin D levels.

      The main purpose of this study is to see whether vitamin D enriched cheese can improve oral
      glucose tolerance (reduce blood glucose 2 hours after consuming a drink containing 75g sugar)
      in people who have low vitamin D levels and are at risk for developing T2D.

      Other aims are to determine the effect of vitamin D may on insulin sensitivity, insulin
      secretion, markers of inflammation, blood cholesterol levels, and safety markers such as
      urinary calcium excretion.
Type 2 diabetes (T2D) is an increasingly prevalent and serious condition whose risk appears
      to be increased by low serum vitamin D concentrations. Epidemiological studies show an
      association between increased diabetes risk and low serum vitamin D and studies suggest that
      vitamin D may protect against diabetes by reducing chronic inflammation and improving insulin
      sensitivity and insulin secretion. Although clinical studies show some of these effects, no
      studies have been able to show that vitamin D supplementation reduces post-prandial blood
      glucose, the most clinically relevant marker of diabetes and dysglycemia. Previously, the
      investigators showed that cheddar cheese and low-fat cheese can be fortified with high levels
      of vitamin D3 (28,000IU/ 30g portion) and that, in this form, it is at least as a effective
      as vitamin D3 supplements in raising serum vitamin D concentrations. Since post-prandial
      glucose is most sensitive to changes in insulin sensitivity the main purpose of this study is
      to determine the effect of vitamin D supplementation on oral glucose tolerance (ie. serum
      glucose 2h after 75g oral glucose) in individuals who are at risk for developing T2D.
      Secondary objective are to determine the effect of vitamin D supplementation on insulin
      sensitivity, insulin secretion, inflammatory markers, blood lipids and markers of safety
      including serum parathyroid hormone levels and urinary calcium excretion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in plasma glucose concentration 2 hours after consuming 75g oral glucose (2 hour PC glucose, or 2hrPC glucose)
time frame: 24 Weeks
description: Change from baseline in plasma glucose concentration 2 hours after consuming 75g oral glucose.
measure: Change in insulin resistance assessed using the homeostasis model assessment of insulin resistance (HOMA-IR)
time frame: 24 weeks
description: Change from baseline in homeostasis model assessment of insulin resistance (HOMA-IR) which is G*I/22.5 where G is fasting plasma glucose (mmol/L) and I is fasting plasma insulin (uU/mL).
measure: Change in Matsuda insulin sensitivity index
time frame: 24 weeks
description: Change from baseline in Matsuda insulin sensitivity index which is (10,000/square root of [fasting glucose x fasting insulin] x [mean glucose x mean insulin during OGTT]).
measure: Change in insulin secretion assessed using the homeostasis model assessment of beta-cell function (HOMA-B)
time frame: 24 weeks
description: Change from baseline in homeostasis model assessment of beta-cell function (HOMA-B) which is 20*I/(G-3.5) where I is fasting plasma insulin (uU/mL) and G is fasting plasma glucose (mmol/L).
measure: Change in insulinogenic index
time frame: 24 weeks
description: Change from baseline in insulinogenic index which is dI0-30/dG0-30, where dI0-30 is the change in plasma insulin between fasting and 30min and dG0-30 is the change in plasma glucose between fasting and 30min after 75g oral glucose.
measure: Change in disposition index derived from HOMA-IR and HOMA-B
time frame: 24 weeks
description: Change from baseline in disposition index which is HOMA-B/HOMA-IR, which have been defined above.
measure: Change in disposition index based on oral glucose tolerance test (OGTT)
time frame: 24 weeks
description: Change from baseline in ISSI-2 index which is AUCi/AUCg x Matsuda insulin sensitivity index, where AUCi and AUCg, respectively, are the total areas under the plasma insulin and glucose response curves after 75g oral glucose and Matsuda insulin sensitivity index has been defined above.
measure: Change in fasting plasma glucose
time frame: 24 weeks
description: Change from baseline in fasting plasma glucose
measure: Change in glucose area under the curve
time frame: 24 weeks
description: Change from baseline in incremental area under the glucose response curve after 75g oral glucose
measure: Change in glycated hemoglobin
time frame: 24 weeks
description: Change from baseline in glycated hemoglobin (HbA1c)
measure: Correlation between changes in serum 25-hydroxy-vitamin D concentration (25(OH)D) and changes in 2 hour PC glucose
time frame: 24 weeks
description: Correlation between change from baseline in serum 25-hydroxy-vitamin D concentration and change from baseline in plasma glucose 2 hours after 75g oral glucose.
measure: Fasting serum 25(OH)D
time frame: 24 weeks
description: Absolute concentration of serum 25-hydroxy-vitamin D3
measure: Change in serum 25(OH)D
time frame: 24 weeks
description: Change from baseline in serum 25-hydroxy-vitamin D3
measure: Change in serum total cholesterol
time frame: 24 weeks
description: Change from baseline in fasting serum total cholesterol
measure: Change in serum low-density lipoprotein (LDL) cholesterol
time frame: 24 weeks
description: Change from baseline in fasting serum calculated LDL cholesterol
measure: Change in serum high-density lipoprotein (HDL) cholesterol
time frame: 24 weeks
description: Change from baseline in fasting serum HDL cholesterol
measure: Change in serum triglycerides
time frame: 24 weeks
description: Change from baseline in fasting serum triglycerides
measure: Change in serum apolipoprotein B (apoB)
time frame: 24 weeks
description: Change from baseline in fasting serum apolipoprotein B
measure: Change in serum c-reactive protein (CRP)
time frame: 24 weeks
description: Change from baseline in fasting serum c-reactive protein
measure: Change in serum orosomucoid
time frame: 24 weeks
description: Change from baseline in fasting serum orosomucoid
measure: Change in serum haptoglobin
time frame: 24 weeks
description: Change from baseline in fasting serum haptoglobin
measure: Change in serum alpha-1-antitrypsin
time frame: 24 weeks
description: Change from baseline in fasting serum alpha-1-antitrypsin
measure: Change in serum aspartate aminotransferase (AST)
time frame: 24 weeks
description: Change from baseline in fasting serum aspartate aminotransferase
measure: Change in serum alanine aminotransferase (ALT)
time frame: 24 weeks
description: Change from baseline in fasting serum alanine aminotransferase
measure: Serum calcium
time frame: 24 weeks
description: Absolute concentration of serum calcium
measure: Urinary calcium:creatinine ratio
time frame: 24 weeks
description: Urinary calcium:creatinine ratio
arm group label: Control
arm group type: Placebo Comparator
description: 30g normal cheddar cheese once per week
arm group label: Vitamin D
arm group type: Experimental
description: 30g cheddar cheese containing 28,000IU vitamin D once per week
intervention type: Dietary Supplement
intervention name: Control
description: Normal cheddar cheese
arm group label: Control
intervention type: Dietary Supplement
intervention name: Vitamin D
description: Vitamin D3 supplemented cheddar cheese
arm group label: Vitamin D
other name: Vitamin D3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Thomas MS Wolever, DM, PhD
role: Principal Investigator
affiliation: University of Toronto
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: Thomas Wolever
investigator title: Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins