The Effect of Coffee Consumption on the Intestinal Absorption of Levothyroxine Thyroid Hormone Replacement in Patients With Thyroid Carcinoma
Black Coffee
+ Coffee with Milk
+ Black Tea
Enfermedades del Sistema Endocrino+5
+ Neoplasias de Glándulas Endocrinas
+ Neoplasias de cabeza y cuello
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de septiembre de 2012
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 60 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.4 grupos de intervención están designados en este estudio
25% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
Comparador ActivoGrupo III
Comparador ActivoGrupo IV
PlaceboObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 3 ubicaciones
Georgetown University Hospital
Washington D.C., United StatesAbrir Georgetown University Hospital en Google MapsWashington Hospital Center
Washington D.C., United StatesMedStar St. Mary's Hospital
Leonardtown, United States