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

This study is currently recruiting participants.
Verified May 2013 by Washington Hospital Center
Sponsor:
Collaborator:
Georgetown University
Information provided by (Responsible Party):
Washington Hospital Center
ClinicalTrials.gov Identifier:
NCT01707056
First received: October 5, 2012
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Thyroid Carcinoma
Hypothyroidism
Other: Black Coffee
Other: Coffee with Milk
Other: Black Tea
Other: Water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Coffee Consumption on the Intestinal Absorption of Levothyroxine Thyroid Hormone Replacement in Patients With Thyroid Carcinoma

Resource links provided by NLM:


Further study details as provided by Washington Hospital Center:

Primary Outcome Measures:
  • Change in TSH (thyrotropin-stimulating-hormone) with each beverage type [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    1. change in TSH over 6 hours
    2. peak change in TSH over 6 hours


Secondary Outcome Measures:
  • Change in TSH with various beverages [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in total T4 with each beverage type [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    1. Change in total T4 over 6 hours
    2. Peak change in total T4 over 6 hours
    3. area under the curve (AUC) for total T4

  • Change in free T4 with each beverage type [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    1. Change in free T4 over 6 hours
    2. Peak change in free T4 over 6 hours
    3. area under the curve (AUC) for free T4

  • Change in total T3 with each beverage type [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    1. Change in total T3 over 6 hours
    2. Peak change in total T3 over 6 hours
    3. area under the curve (AUC) for total T3


Estimated Enrollment: 10
Study Start Date: September 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Black coffee
Synthroid will be administered with 12 ounces of black coffee for a period of 6 weeks.
Other: Black Coffee
Taking Synthroid with 12 ounces of black coffee for 6 weeks.
Active Comparator: Coffee with Milk
Synthroid will be administered with 12 ounces of coffee and 2 ounces of 2% milk for a period of 6 weeks.
Other: Coffee with Milk
Taking Synthroid with 12 ounces of black coffee and 2 ounces of 2% milk for a period of 6 weeks.
Active Comparator: Black Tea
Synthroid will be administered with 12 ounces of black Lipton tea for a period of 6 weeks.
Other: Black Tea
Taking Synthroid with 12 ounces of black tea for a period of 6 weeks.
Placebo Comparator: Water
Synthroid will be administered with 12 ounces of water for a period of 6 weeks.
Other: Water
Taking Synthroid with water for a period of 6 weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707056

Contacts
Contact: Dorota Krajewski, MD (301) 475-7750 dorotak79@yahoo.com
Contact: Jaqueline Jonklaas, MD (202) 687-2818 jonklaaj@georgetown.edu

Locations
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Kenneth D Burman, MD    202-877-6563    Kenneth.d.burman@medstar.net   
Principal Investigator: Kenneth D Burman, MD         
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Jacqueline Jonklaas, MD    202-687-2818    jonklaaj@georgetown.edu   
Principal Investigator: Jacqueline Jonklaas, MD         
United States, Maryland
MedStar St. Mary's Hospital Recruiting
Leonardtown, Maryland, United States, 20650
Contact: Dorota A Krajewski, MD    301-475-7750    dorotak79@yahoo.com   
Principal Investigator: Dorota A Krajewski, MD         
Sponsors and Collaborators
Washington Hospital Center
Georgetown University
Investigators
Principal Investigator: Dorota Krajewski, MD MedStar
  More Information

Publications:
Responsible Party: Washington Hospital Center
ClinicalTrials.gov Identifier: NCT01707056     History of Changes
Other Study ID Numbers: 2011-338
Study First Received: October 5, 2012
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington Hospital Center:
levothyroxine
synthroid
coffee
absorption
tea
thyroid carcinoma

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Carcinoma
Hypothyroidism
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014