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Clinical Trial to Compare Natural Desiccated Thyroid to Levothyroxine

NIH Recruiting Hypothyroid Patients for New Study

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Updated December 28, 2012

Clinical Trial to Compare Natural Desiccated Thyroid to Levothyroxine

The question of whether some patients benefit from natural desiccated thyroid drugs -- instead of levothyroxine -- will be explored by a study conducted by the NIH.

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It's an exciting day for thyroid patients, and one that has been long-awaited. The U.S. National Institutes of Health has announced that a clinical trial has just been started in 2012 at the Walter Reed National Military Medical Center, in Bethesda, MD, to study natural desiccated thyroid drugs versus levothyroxine, for the treatment of primary hypothyroidism.

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.

Eligibility

You 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.)

Exclusions

You 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
If you are in the military and have recent PCS (Permanent Change of Station) military orders and are expected to move out of the geographic area, or you are scheduled for military deployment, you are also not eligible.

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 Trial

If you meet the qualifications and are interested in being recruited to participate in this clinical trial, contact: Mohamed Shakir, MD, 301-295-5165, mohamed.shakir@med.navy.mil and Patrick Clyde, MD, 301-295-5165, patrick.clyde@med.navy.mil.

The clinical Trials.gov identifier number for this trial is NCT01739972.

You can see the full ClinicalTrials.gov listing.

Questions About Clinical Trials?

You can learn more about clinical trials, how they are conducted, and how to participate, at the NIH's Clinical Trials page.

If You Are Successfully Recruited Into This Trial

If you are successfully recruited into this trial, please keep in touch with me by email to keep me posted on how it goes for you.

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