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

Information source: Washington Hospital Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thyroid Carcinoma; Hypothyroidism

Intervention: Black Coffee (Other); Coffee with Milk (Other); Black Tea (Other); Water (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Washington Hospital Center

Official(s) and/or principal investigator(s):
Dorota Krajewski, MD, Principal Investigator, Affiliation: MedStar

Overall contact:
Dorota Krajewski, MD, Phone: (301) 475-7750, Email: dorotak79@yahoo.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

Change in TSH with various beverages

Change in total T4 with each beverage type

Change in free T4 with each beverage type

Change in total T3 with each beverage type

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

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Dorota Krajewski, MD, Phone: (301) 475-7750, Email: dorotak79@yahoo.com

Georgetown University Hospital, Washington, District of Columbia 20007, United States; Recruiting
Jacqueline Jonklaas, MD, Phone: 202-687-2818, Email: jonklaaj@georgetown.edu
Jacqueline Jonklaas, MD, Principal Investigator

Washington Hospital Center, Washington, District of Columbia 20010, United States; Recruiting
Kenneth D Burman, MD, Phone: 202-877-6563, Email: Kenneth.d.burman@medstar.net
Kenneth D Burman, MD, Principal Investigator

MedStar St. Mary's Hospital, Leonardtown, Maryland 20650, United States; Recruiting
Dorota A Krajewski, MD, Phone: 301-475-7750, Email: dorotak79@yahoo.com
Dorota A Krajewski, MD, Principal Investigator

Additional Information

Related publications:

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.

Starting date: September 2012
Last updated: May 21, 2013

Page last updated: August 23, 2015

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