<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/NCT01707056</url>
  </required_header>
  <id_info>
    <org_study_id>2011-338</org_study_id>
    <nct_id>NCT01707056</nct_id>
  </id_info>
  <brief_title>The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma</brief_title>
  <official_title>The Effect of Coffee Consumption on the Intestinal Absorption of Levothyroxine Thyroid Hormone Replacement in Patients With Thyroid Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medstar Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medstar Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate whether taking thyroid hormone medication with&#xD;
      beverages other than water, decreases absorption of the medication by the intestine.&#xD;
      Specifically we are interested in whether coffee, coffee with milk, or black tea affects how&#xD;
      thyroid medication is absorbed by the body. Previous studies have suggested that taking&#xD;
      thyroid hormone with coffee may interfere with the ability to absorb thyroid medicine. Given&#xD;
      that many patients take their thyroid medicine with beverages other than water, and&#xD;
      specifically with coffee or tea, understanding whether and how much coffee or tea may&#xD;
      decrease thyroid hormone absorption is important for clinical practice.&#xD;
&#xD;
      This study will help determine the safest and most effective way for adults to take their&#xD;
      thyroid medication and will guide medical practitioners in how to counsel their patients when&#xD;
      they prescribe thyroid hormone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies have suggested that taking thyroid replacement therapy with coffee&#xD;
      potentially hinders its absorption. We already know that food especially a fiber-rich diet,&#xD;
      cholestyramine resin, aluminum containing antacids, activated charcoal, and certain herbal&#xD;
      remedies among others interfere with the ability to absorb thyroid medicine. These findings&#xD;
      have prompted providers to advise patients to take their levothyroxine on an empty stomach in&#xD;
      the morning. However, many patients take their thyroid medicine with their morning cup of&#xD;
      coffee prior to eating breakfast. A small study has shown that Italian espresso coffee can&#xD;
      decrease the absorption of levothyroxine, but the effect of American style coffee is not&#xD;
      known. Given that the intestinal absorption of levothyroxine can be hindered by multiple&#xD;
      substances and coffee is the most commonly consumed beverage worldwide, it is important to&#xD;
      investigate what effect coffee may have on thyroid hormone absorption and thyroid function&#xD;
      tests.&#xD;
&#xD;
      Using methods similar to those used in previous studies, this study will measure thyroid&#xD;
      function tests in approximately 10-20 subjects (18-60 years of age) over a 6 hour period of&#xD;
      time after taking their thyroid medication with the specified study beverage for a 6 week&#xD;
      period. Subjects will be randomized to water, black coffee, coffee with milk, and black tea&#xD;
      as four specified study beverages, with water serving as the control beverage. Each subject&#xD;
      will be recruited to participate with each study beverage for a 6 week period of time in a&#xD;
      total of four consecutive 6 week periods. Blood draws will occur at the end of each 6 week&#xD;
      period on test days 1, 2, 3, and 4. The coffee will represent the most common household&#xD;
      coffee brand, Folgers. Thyroid function tests with each beverage will be compared to thyroid&#xD;
      function tests with water to determine if thyroid medication absorption is impaired by&#xD;
      coffee, coffee with milk, or tea.&#xD;
&#xD;
      This study will help determine the safest and most efficacious way for adults to take their&#xD;
      thyroid medication and will guide medical practitioners in how to counsel their patients when&#xD;
      they prescribe thyroid replacement therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in TSH (thyrotropin-stimulating-hormone) with each beverage type</measure>
    <time_frame>6 hours</time_frame>
    <description>change in TSH over 6 hours&#xD;
peak change in TSH over 6 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in TSH with various beverages</measure>
    <time_frame>6 weeks</time_frame>
    <description>To determine if taking Synthroid for 6 weeks with each of the prescribed study beverages results in a different baseline TSH, reflecting altered absorption of levothyroxine with each particular beverage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total T4 with each beverage type</measure>
    <time_frame>6 hours</time_frame>
    <description>Change in total T4 over 6 hours&#xD;
Peak change in total T4 over 6 hours&#xD;
area under the curve (AUC) for total T4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in free T4 with each beverage type</measure>
    <time_frame>6 hours</time_frame>
    <description>Change in free T4 over 6 hours&#xD;
Peak change in free T4 over 6 hours&#xD;
area under the curve (AUC) for free T4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total T3 with each beverage type</measure>
    <time_frame>6 hours</time_frame>
    <description>Change in total T3 over 6 hours&#xD;
Peak change in total T3 over 6 hours&#xD;
area under the curve (AUC) for total T3</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Thyroid Carcinoma</condition>
  <condition>Hypothyroidism</condition>
  <arm_group>
    <arm_group_label>Black coffee</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Synthroid will be administered with 12 ounces of black coffee for a period of 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Coffee with Milk</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Synthroid will be administered with 12 ounces of coffee and 2 ounces of 2% milk for a period of 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Black Tea</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Synthroid will be administered with 12 ounces of black Lipton tea for a period of 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Synthroid will be administered with 12 ounces of water for a period of 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Black Coffee</intervention_name>
    <description>Taking Synthroid with 12 ounces of black coffee for 6 weeks.</description>
    <arm_group_label>Black coffee</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Coffee with Milk</intervention_name>
    <description>Taking Synthroid with 12 ounces of black coffee and 2 ounces of 2% milk for a period of 6 weeks.</description>
    <arm_group_label>Coffee with Milk</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Black Tea</intervention_name>
    <description>Taking Synthroid with 12 ounces of black tea for a period of 6 weeks.</description>
    <arm_group_label>Black Tea</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water</intervention_name>
    <description>Taking Synthroid with water for a period of 6 weeks.</description>
    <arm_group_label>Water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - patients with thyroid carcinoma after standard care of treatment on stable dose of&#xD;
        Synthroid with a detectable baseline TSH&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Undetectable baseline TSH&#xD;
&#xD;
          -  Not willing to drink coffee, coffee with milk, or black tea&#xD;
&#xD;
          -  Age less than 18 or greater than 60 years old&#xD;
&#xD;
          -  Taking generic thyroid hormone (levothyroxine) and not brand-name Synthroid&#xD;
&#xD;
          -  Dose of thyroid medication has been recently changed (less than 3 months ago)&#xD;
&#xD;
          -  Currently receiving treatment for gastroesophageal reflux disease, gastritis, stomach&#xD;
             or intestinal cancer, inflammatory bowel disease, or H. pylori&#xD;
&#xD;
          -  Taking cholestyramine resin, colestipol hydrochloride, sucralfate, iron sulphate,&#xD;
             aluminum containing antacids, activated charcoal, raloxifene, and herbal remedies&#xD;
&#xD;
          -  History of previous gastric or small intestine surgery&#xD;
&#xD;
          -  Diagnosis of kidney or liver disease, congestive heart failure, anemia, biliary&#xD;
             disease, pancreatitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dorota Krajewski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medstar</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar St. Mary's Hospital</name>
      <address>
        <city>Leonardtown</city>
        <state>Maryland</state>
        <zip>20650</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Benvenga S, Bartolone L, Pappalardo MA, Russo A, Lapa D, Giorgianni G, Saraceno G, Trimarchi F. Altered intestinal absorption of L-thyroxine caused by coffee. Thyroid. 2008 Mar;18(3):293-301. doi: 10.1089/thy.2007.0222.</citation>
    <PMID>18341376</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>February 15, 2021</last_update_submitted>
  <last_update_submitted_qc>February 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>levothyroxine</keyword>
  <keyword>synthroid</keyword>
  <keyword>coffee</keyword>
  <keyword>absorption</keyword>
  <keyword>tea</keyword>
  <keyword>thyroid carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
    <mesh_term>Hypothyroidism</mesh_term>
  </condition_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/NCT01707056
org study id: 2011-338
nct id: NCT01707056
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate whether taking thyroid hormone medication with
      beverages other than water, decreases absorption of the medication by the intestine.
      Specifically we are interested in whether coffee, coffee with milk, or black tea affects how
      thyroid medication is absorbed by the body. Previous studies have suggested that taking
      thyroid hormone with coffee may interfere with the ability to absorb thyroid medicine. Given
      that many patients take their thyroid medicine with beverages other than water, and
      specifically with coffee or tea, understanding whether and how much coffee or tea may
      decrease thyroid hormone absorption is important for clinical practice.

      This study will help determine the safest and most effective way for adults to take their
      thyroid medication and will guide medical practitioners in how to counsel their patients when
      they prescribe thyroid hormone.
Previous studies have suggested that taking thyroid replacement therapy with coffee
      potentially hinders its absorption. We already know that food especially a fiber-rich diet,
      cholestyramine resin, aluminum containing antacids, activated charcoal, and certain herbal
      remedies among others interfere with the ability to absorb thyroid medicine. These findings
      have prompted providers to advise patients to take their levothyroxine on an empty stomach in
      the morning. However, many patients take their thyroid medicine with their morning cup of
      coffee prior to eating breakfast. A small study has shown that Italian espresso coffee can
      decrease the absorption of levothyroxine, but the effect of American style coffee is not
      known. Given that the intestinal absorption of levothyroxine can be hindered by multiple
      substances and coffee is the most commonly consumed beverage worldwide, it is important to
      investigate what effect coffee may have on thyroid hormone absorption and thyroid function
      tests.

      Using methods similar to those used in previous studies, this study will measure thyroid
      function tests in approximately 10-20 subjects (18-60 years of age) over a 6 hour period of
      time after taking their thyroid medication with the specified study beverage for a 6 week
      period. Subjects will be randomized to water, black coffee, coffee with milk, and black tea
      as four specified study beverages, with water serving as the control beverage. Each subject
      will be recruited to participate with each study beverage for a 6 week period of time in a
      total of four consecutive 6 week periods. Blood draws will occur at the end of each 6 week
      period on test days 1, 2, 3, and 4. The coffee will represent the most common household
      coffee brand, Folgers. Thyroid function tests with each beverage will be compared to thyroid
      function tests with water to determine if thyroid medication absorption is impaired by
      coffee, coffee with milk, or tea.

      This study will help determine the safest and most efficacious way for adults to take their
      thyroid medication and will guide medical practitioners in how to counsel their patients when
      they prescribe thyroid replacement therapy.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in TSH (thyrotropin-stimulating-hormone) with each beverage type
time frame: 6 hours
description: change in TSH over 6 hours
peak change in TSH over 6 hours
measure: Change in TSH with various beverages
time frame: 6 weeks
description: To determine if taking Synthroid for 6 weeks with each of the prescribed study beverages results in a different baseline TSH, reflecting altered absorption of levothyroxine with each particular beverage.
measure: Change in total T4 with each beverage type
time frame: 6 hours
description: Change in total T4 over 6 hours
Peak change in total T4 over 6 hours
area under the curve (AUC) for total T4
measure: Change in free T4 with each beverage type
time frame: 6 hours
description: Change in free T4 over 6 hours
Peak change in free T4 over 6 hours
area under the curve (AUC) for free T4
measure: Change in total T3 with each beverage type
time frame: 6 hours
description: Change in total T3 over 6 hours
Peak change in total T3 over 6 hours
area under the curve (AUC) for total T3
arm group label: Black coffee
arm group type: Active Comparator
description: Synthroid will be administered with 12 ounces of black coffee for a period of 6 weeks.
arm group label: Coffee with Milk
arm group type: Active Comparator
description: Synthroid will be administered with 12 ounces of coffee and 2 ounces of 2% milk for a period of 6 weeks.
arm group label: Black Tea
arm group type: Active Comparator
description: Synthroid will be administered with 12 ounces of black Lipton tea for a period of 6 weeks.
arm group label: Water
arm group type: Placebo Comparator
description: Synthroid will be administered with 12 ounces of water for a period of 6 weeks.
intervention type: Other
intervention name: Black Coffee
description: Taking Synthroid with 12 ounces of black coffee for 6 weeks.
arm group label: Black coffee
intervention type: Other
intervention name: Coffee with Milk
description: Taking Synthroid with 12 ounces of black coffee and 2 ounces of 2% milk for a period of 6 weeks.
arm group label: Coffee with Milk
intervention type: Other
intervention name: Black Tea
description: Taking Synthroid with 12 ounces of black tea for a period of 6 weeks.
arm group label: Black Tea
intervention type: Other
intervention name: Water
description: Taking Synthroid with water for a period of 6 weeks.
arm group label: Water
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Dorota Krajewski, MD
role: Principal Investigator
affiliation: Medstar
facility: 
facility: 
facility: 
country: United States
citation: Benvenga S, Bartolone L, Pappalardo MA, Russo A, Lapa D, Giorgianni G, Saraceno G, Trimarchi F. Altered intestinal absorption of L-thyroxine caused by coffee. Thyroid. 2008 Mar;18(3):293-301. doi: 10.1089/thy.2007.0222.
PMID: 18341376
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases
mesh term: Hypothyroidism