Clinical trial NCT01707056: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Thyroid Carcinoma
Hypothyroidism
Keywords: levothyroxine
synthroid
coffee
absorption
tea
thyroid carcinoma
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Georgetown University
First posted: 2012-10-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in TSH (thyrotropin-stimulating-hormone) with each beverage type
timeFrame: 6 hours
Secondary outcomes:
measure: Change in TSH with various beverages
timeFrame: 6 weeks
measure: Change in total T4 with each beverage type
timeFrame: 6 hours
measure: Change in free T4 with each beverage type
timeFrame: 6 hours
measure: Change in total T3 with each beverage type
timeFrame: 6 hours
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Leonardtown
country: United States
facility: MedStar St. Mary's Hospital
state: Maryland
Study officials:
affiliation: MedStar Health
name: Dorota Krajewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.