Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Georgetown University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Black coffee | Active Comparator | Synthroid will be administered with 12 ounces of black coffee for a period of 6 weeks. |
|
| 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. |
|
| Black Tea | Active Comparator | Synthroid will be administered with 12 ounces of black Lipton tea for a period of 6 weeks. |
|
| Water | Placebo Comparator | Synthroid will be administered with 12 ounces of water for a period of 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Black Coffee | Other | Taking Synthroid with 12 ounces of black coffee for 6 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TSH (thyrotropin-stimulating-hormone) with each beverage type |
| 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Change in total T4 with each beverage type |
Not provided
Inclusion Criteria:
- patients with thyroid carcinoma after standard care of treatment on stable dose of Synthroid with a detectable baseline TSH
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dorota Krajewski, MD | MedStar Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States | ||
| Washington Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18341376 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003069 | Coffee |
| D008892 | Milk |
| D013662 | Tea |
| D014867 | Water |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Coffee with Milk |
| Other |
Taking Synthroid with 12 ounces of black coffee and 2 ounces of 2% milk for a period of 6 weeks. |
|
| Black Tea | Other | Taking Synthroid with 12 ounces of black tea for a period of 6 weeks. |
|
| Water | Other | Taking Synthroid with water for a period of 6 weeks. |
|
|
| 6 hours |
| Change in free T4 with each beverage type |
| 6 hours |
| Change in total T3 with each beverage type |
| 6 hours |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| MedStar St. Mary's Hospital | Leonardtown | Maryland | 20650 | United States |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D003611 | Dairy Products |
| D005502 | Food |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |