The randomized, cross-over study -- which goes through May of 2014 -- will evaluate the hypothesis that hypothyroid patients on natural desiccated thyroid (what they refer to as "dessicated thyroid extract" or DTE) may have "a decrease in symptoms, an improvement of cognitive function, and an increase in sense of well-being / quality of life," when compared with levothyroxine.
The official title of the study is "Desiccated Thyroid Extract Compared to Levothyroxine in the Treatment of Hypothyroidism: A Randomized, Double-blind, Crossover Study," and they are recruiting thyroid patients as study participants.
EligibilityYou are eligible to participate in this study if you are a man or woman, between 18 and 65 years of age. and have been on levothyroxine for primary hypothyroidism for at least 6 months. (NOTE: Only active or retired members of the military and their beneficiaries are eligible for this trial.)
ExclusionsYou will be excluded from the study if you have any of the following conditions or issues:
- pregnancy or plan for pregnancy in the next 12 months
- cardiac disease, especially coronary artery disease
- chronic obstructive lung disease
- malabsorption disorder
- gastrointestinal surgeries
- significant renal or liver dysfunction
- seizure disorders
- thyroid and non-thyroid active cancers
- uncontrolled psychosis
- psychotropic medication use
- steroid use
- amiodarone use
- chemotherapy for cancer
- iron supplement more than 325mg per day
- carafate/ proton pump inhibitor use
- cholestyramine use
Why is This Trial Important?This trial is important because it's the first time in recent history that I am aware of that a nationally recognized medical research body -- in this case, the U.S. National Institutes of Health -- is conducting double-blind, cross-over research to compare symptoms, cognitive function, well-being, and quality of life in hypothyroid patients on natural desiccated thyroid drugs, versus the more commonly prescribed levothyroxine.
This trial is also important because there is a strong bias among conventional endocrinologists against prescribing natural desiccated thyroid drugs, but it is not based on research, but rather, their own opinions and preferences. Some endocrinologists, in fact, have even said that natural thyroid drugs like Armour are only taken by the "fringe", despite the fact that more than two million prescriptions for these drugs are written each year in the United States alone, and more around the world.
This trial is also important because we need research that looks specifically at the use of natural desiccated thyroid. Some studies, including the 2009 Danish study, have shown quality of life improvements with the addition of synthetic T3 to synthetic T4 (levothyroxine), but some physicians have said that these studies are not relevant when considering natural desiccated thyroid drugs (which naturally contain both T3 and T4) because they are different drugs.
To Participate in the TrialIf you meet the qualifications and are interested in being recruited to participate in this clinical trial, contact: Mohamed Shakir, MD, 301-295-5165, email@example.com and Patrick Clyde, MD, 301-295-5165, firstname.lastname@example.org.
The clinical Trials.gov identifier number for this trial is NCT01739972.