Suspended

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

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What is being tested

Black Coffee

+ Coffee with Milk

+ Black Tea

Other
Who is being recruted

Endocrine System Diseases+5

+ Endocrine Gland Neoplasms

+ Head and Neck Neoplasms

From 18 to 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorMedstar Health Research Institute
Last updated: February 17, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorMedstar Health Research Institute
Last updated: February 17, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesEndocrine Gland NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by SiteThyroid DiseasesHypothyroidismThyroid Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Group III

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

Group IV

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Georgetown University Hospital

Washington D.C., United StatesOpen Georgetown University Hospital in Google Maps

Washington Hospital Center

Washington D.C., United States

MedStar St. Mary's Hospital

Leonardtown, United States
Suspended3 Study Centers