Thyroid CarcinomaNCT01707056
The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma
A study testing Black Coffee, Coffee with Milk and Black Tea in people with Thyroid Carcinoma and Hypothyroidism, run by Medstar Health Research Institute at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thyroid Carcinoma, Hypothyroidism
- What is being tested?
- Black Coffee, Coffee with Milk and Black Tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with thyroid carcinoma after standard care of treatment on stable dose of Synthroid with a detectable baseline TSH
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
MedStar St. Mary's Hospital
Leonardtown, Maryland, 20650
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: The Effect of Coffee Consumption on the Intestinal Absorption of Levothyroxine Thyroid Hormone Replacement in Patients With Thyroid Carcinoma
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.
Read the 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.
- Conditions
- Thyroid Carcinoma, Hypothyroidism
- Being tested
- Black Coffee, Coffee with Milk, Black Tea, Water
- Keywords
- levothyroxine, synthroid, coffee, absorption, tea, thyroid carcinoma
- Medical subject headings
- Thyroid Neoplasms, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black CoffeeOther
Taking Synthroid with 12 ounces of black coffee for 6 weeks.
Coffee with MilkOther
Taking Synthroid with 12 ounces of black coffee and 2 ounces of 2% milk for a period of 6 weeks.
Black TeaOther
Taking Synthroid with 12 ounces of black tea for a period of 6 weeks.
WaterOther
Taking Synthroid with water for a period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Black coffee | Active comparator | Synthroid will be administered with 12 ounces of black coffee for a period of 6 weeks. Receives: Other: Black Coffee |
| Coffee with Milk | Active comparator | Synthroid will be administered with 12 ounces of coffee and 2 ounces of 2% milk for a period of 6 weeks. Receives: Other: Coffee with Milk |
| Black Tea | Active comparator | Synthroid will be administered with 12 ounces of black Lipton tea for a period of 6 weeks. Receives: Other: Black Tea |
| Water | Placebo comparator | Synthroid will be administered with 12 ounces of water for a period of 6 weeks. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TSH (thyrotropin-stimulating-hormone) with each beverage type
- change in TSH over 6 hours
- peak change in TSH over 6 hours
Measured: 6 hours
Secondary outcomes (4)
Change in TSH with various beverages
To determine if taking Synthroid for 6 weeks with each of the prescribed study beverages results in a different baseline TSH, reflecting altered absorption of levothyroxine with each particular beverage.
Measured: 6 weeks
Change in total T4 with each beverage type
- Change in total T4 over 6 hours
- Peak change in total T4 over 6 hours
- area under the curve (AUC) for total T4
Measured: 6 hours
Change in free T4 with each beverage type
- Change in free T4 over 6 hours
- Peak change in free T4 over 6 hours
- area under the curve (AUC) for free T4
Measured: 6 hours
Change in total T3 with each beverage type
- Change in total T3 over 6 hours
- Peak change in total T3 over 6 hours
- area under the curve (AUC) for total T3
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Georgetown University
- Responsible party
- Sponsor
- Investigators
- Dorota Krajewski, MD, Principal investigator, MedStar Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707056
- Sponsor's protocol ID
- 2011-338
- Status last verified
- Feb 2021
- First submitted
- 5 Oct 2012
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18341376
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coffee Consumption on the Intestinal Absorption of Levothyroxine Thyroid Hormone Replacement in Patients With Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT01707056
- Acronym / sponsor ID
- 2011-338
- Conditions
- Thyroid Carcinoma, Hypothyroidism
- Keywords
- levothyroxine, synthroid, coffee, absorption, tea, thyroid carcinoma
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Georgetown University
- Study start
- Sep 2012 (actual)
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Black coffee | Active comparator | Other: Black CoffeeSynthroid will be administered with 12 ounces of black coffee for a period of 6 weeks. |
| Coffee with Milk | Active comparator | Other: Coffee with MilkSynthroid will be administered with 12 ounces of coffee and 2 ounces of 2% milk for a period of 6 weeks. |
| Black Tea | Active comparator | Other: Black TeaSynthroid will be administered with 12 ounces of black Lipton tea for a period of 6 weeks. |
| Water | Placebo comparator | Other: WaterSynthroid will be administered with 12 ounces of water for a period of 6 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with thyroid carcinoma after standard care of treatment on stable dose of Synthroid with a detectable baseline TSH
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black CoffeeTaking Synthroid with 12 ounces of black coffee for 6 weeks. | Other | Black coffee |
| Coffee with MilkTaking Synthroid with 12 ounces of black coffee and 2 ounces of 2% milk for a period of 6 weeks. | Other | Coffee with Milk |
| Black TeaTaking Synthroid with 12 ounces of black tea for a period of 6 weeks. | Other | Black Tea |
| WaterTaking Synthroid with water for a period of 6 weeks. | Other | Water |
Primary outcome
Change in TSH (thyrotropin-stimulating-hormone) with each beverage type
Time frame: 6 hours
1. change in TSH over 6 hours 2. peak change in TSH over 6 hours
4 secondary outcomes
Change in TSH with various beverages
Time frame: 6 weeks
Change in total T4 with each beverage type
Time frame: 6 hours
Change in free T4 with each beverage type
Time frame: 6 hours
Change in total T3 with each beverage type
Time frame: 6 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Background: PubMed 18341376Benvenga 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorota Krajewski, MD principal investigator
MedStar Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black Coffee, Coffee with Milk and Black Tea in people with Thyroid Carcinoma and Hypothyroidism, run by Medstar Health Research Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TSH (thyrotropin-stimulating-hormone) with each beverage type (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01707056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.