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

Primary Purpose

Thyroid Carcinoma, Hypothyroidism

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Black Coffee
Coffee with Milk
Black Tea
Water
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Carcinoma focused on measuring levothyroxine, synthroid, coffee, absorption, tea, thyroid carcinoma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown University Hospital
  • Washington Hospital Center
  • MedStar St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Black coffee

Coffee with Milk

Black Tea

Water

Arm Description

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

Synthroid will be administered with 12 ounces of coffee and 2 ounces of 2% milk for a period of 6 weeks.

Synthroid will be administered with 12 ounces of black Lipton tea for a period of 6 weeks.

Synthroid will be administered with 12 ounces of water for a period of 6 weeks.

Outcomes

Primary Outcome Measures

Change in TSH (thyrotropin-stimulating-hormone) with each beverage type
change in TSH over 6 hours peak change in TSH over 6 hours

Secondary Outcome Measures

Change in TSH with various beverages
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
Change in total T4 over 6 hours Peak change in total T4 over 6 hours area under the curve (AUC) for total T4
Change in free T4 with each beverage type
Change in free T4 over 6 hours Peak change in free T4 over 6 hours area under the curve (AUC) for free T4
Change in total T3 with each beverage type
Change in total T3 over 6 hours Peak change in total T3 over 6 hours area under the curve (AUC) for total T3

Full Information

First Posted
October 5, 2012
Last Updated
February 15, 2021
Sponsor
Medstar Health Research Institute
Collaborators
Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT01707056
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Study Start Date
September 2012 (Actual)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
Collaborators
Georgetown University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Carcinoma, Hypothyroidism
Keywords
levothyroxine, synthroid, coffee, absorption, tea, thyroid carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Black coffee
Arm Type
Active Comparator
Arm Description
Synthroid will be administered with 12 ounces of black coffee for a period of 6 weeks.
Arm Title
Coffee with Milk
Arm Type
Active Comparator
Arm Description
Synthroid will be administered with 12 ounces of coffee and 2 ounces of 2% milk for a period of 6 weeks.
Arm Title
Black Tea
Arm Type
Active Comparator
Arm Description
Synthroid will be administered with 12 ounces of black Lipton tea for a period of 6 weeks.
Arm Title
Water
Arm Type
Placebo Comparator
Arm Description
Synthroid will be administered with 12 ounces of water for a period of 6 weeks.
Intervention Type
Other
Intervention Name(s)
Black Coffee
Intervention Description
Taking Synthroid with 12 ounces of black coffee for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Coffee with Milk
Intervention Description
Taking Synthroid with 12 ounces of black coffee and 2 ounces of 2% milk for a period of 6 weeks.
Intervention Type
Other
Intervention Name(s)
Black Tea
Intervention Description
Taking Synthroid with 12 ounces of black tea for a period of 6 weeks.
Intervention Type
Other
Intervention Name(s)
Water
Intervention Description
Taking Synthroid with water for a period of 6 weeks.
Primary Outcome Measure Information:
Title
Change in TSH (thyrotropin-stimulating-hormone) with each beverage type
Description
change in TSH over 6 hours peak change in TSH over 6 hours
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Change in TSH with various beverages
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.
Time Frame
6 weeks
Title
Change in total T4 with each beverage type
Description
Change in total T4 over 6 hours Peak change in total T4 over 6 hours area under the curve (AUC) for total T4
Time Frame
6 hours
Title
Change in free T4 with each beverage type
Description
Change in free T4 over 6 hours Peak change in free T4 over 6 hours area under the curve (AUC) for free T4
Time Frame
6 hours
Title
Change in total T3 with each beverage type
Description
Change in total T3 over 6 hours Peak change in total T3 over 6 hours area under the curve (AUC) for total T3
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorota Krajewski, MD
Organizational Affiliation
Medstar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
MedStar St. Mary's Hospital
City
Leonardtown
State/Province
Maryland
ZIP/Postal Code
20650
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18341376
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.
Results Reference
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The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma

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