The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma
The Effect of Coffee Consumption on the Intestinal Absorption of Levothyroxine Thyroid Hormone Replacement in Patients With Thyroid Carcinoma
1 other identifier
interventional
N/A
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2012
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 5, 2012
CompletedFirst Posted
Study publicly available on registry
October 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFebruary 17, 2021
February 1, 2021
2.7 years
October 5, 2012
February 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in TSH (thyrotropin-stimulating-hormone) with each beverage type
1. change in TSH over 6 hours 2. peak change in TSH over 6 hours
6 hours
Secondary Outcomes (4)
Change in TSH with various beverages
6 weeks
Change in total T4 with each beverage type
6 hours
Change in free T4 with each beverage type
6 hours
Change in total T3 with each beverage type
6 hours
Study Arms (4)
Black coffee
ACTIVE COMPARATORSynthroid will be administered with 12 ounces of black coffee for a period of 6 weeks.
Coffee with Milk
ACTIVE COMPARATORSynthroid will be administered with 12 ounces of coffee and 2 ounces of 2% milk for a period of 6 weeks.
Black Tea
ACTIVE COMPARATORSynthroid will be administered with 12 ounces of black Lipton tea for a period of 6 weeks.
Water
PLACEBO COMPARATORSynthroid will be administered with 12 ounces of water for a period of 6 weeks.
Interventions
Taking Synthroid with 12 ounces of black coffee and 2 ounces of 2% milk for a period of 6 weeks.
Eligibility Criteria
You may qualify if:
- \- patients with thyroid carcinoma after standard care of treatment on stable dose of Synthroid with a detectable baseline TSH
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medstar Health Research Institutelead
- Georgetown Universitycollaborator
Study Sites (3)
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
MedStar St. Mary's Hospital
Leonardtown, Maryland, 20650, United States
Related Publications (1)
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.
PMID: 18341376BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dorota Krajewski, MD
MedStar Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2012
First Posted
October 15, 2012
Study Start
September 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2016
Last Updated
February 17, 2021
Record last verified: 2021-02