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

Thyroid Carcinoma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Thyroid Carcinoma

Hypothyroidism

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Black CoffeeTaking Synthroid with 12 ounces of black coffee for 6 weeks.

Other:Coffee with MilkTaking Synthroid with 12 ounces of black coffee and 2 ounces of 2% milk for a period of 6 weeks.

Other:Black TeaTaking Synthroid with 12 ounces of black tea for a period of 6 weeks.

Other:WaterTaking Synthroid with water for a period of 6 weeks.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

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

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

Study Status

Unknown status

Start Date: September 2012

Completed Date: June 2016

Phase: N/A

Type: Interventional

Design:

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

Secondary Outcome: Change in TSH with various beverages

Study sponsors, principal investigator, and references

Principal Investigator: Dorota Krajewski, MD

Lead Sponsor: Washington Hospital Center

Collaborator: Georgetown University

More information:https://clinicaltrials.gov/show/NCT01707056

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.

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