The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma

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Brief Title

The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma

Official Title

The Effect of Coffee Consumption on the Intestinal Absorption of Levothyroxine Thyroid Hormone Replacement in Patients With Thyroid Carcinoma

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

Change in TSH (thyrotropin-stimulating-hormone) with each beverage type

Secondary Outcome

 Change in TSH with various beverages

Condition

Thyroid Carcinoma

Intervention

Black Coffee

Study Arms / Comparison Groups

 Black coffee
Description:  Synthroid will be administered with 12 ounces of black coffee for a period of 6 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

0

Start Date

September 2012

Completion Date

June 2016

Primary Completion Date

June 2015

Eligibility Criteria

        Inclusion Criteria:

        - patients with thyroid carcinoma after standard care of treatment on stable dose of
        Synthroid with a detectable baseline TSH

        Exclusion Criteria:

          -  Pregnancy

          -  Undetectable baseline TSH

          -  Not willing to drink coffee, coffee with milk, or black tea

          -  Age less than 18 or greater than 60 years old

          -  Taking generic thyroid hormone (levothyroxine) and not brand-name Synthroid

          -  Dose of thyroid medication has been recently changed (less than 3 months ago)

          -  Currently receiving treatment for gastroesophageal reflux disease, gastritis, stomach
             or intestinal cancer, inflammatory bowel disease, or H. pylori

          -  Taking cholestyramine resin, colestipol hydrochloride, sucralfate, iron sulphate,
             aluminum containing antacids, activated charcoal, raloxifene, and herbal remedies

          -  History of previous gastric or small intestine surgery

          -  Diagnosis of kidney or liver disease, congestive heart failure, anemia, biliary
             disease, pancreatitis
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Dorota Krajewski, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01707056

Organization ID

2011-338


Responsible Party

Sponsor

Study Sponsor

Medstar Health Research Institute

Collaborators

 Georgetown University

Study Sponsor

Dorota Krajewski, MD, Principal Investigator, Medstar


Verification Date

February 2021