The U.S. National Institutes of Health is sponsoring a clinical trial, and the trial is currently recruiting participants. The trial is titled "Phase II Single Daily-Dose Response Study of a New Liothyronine Sodium (T3) Preparation With Sustained Effects in Hypothyroid Patients." The trial will be investigating the effects of ThyroMax, a sustained release synthetic T3 (liothyronine) drug as a treatment for hypothyroidism.
According to the listing at Clinicaltrials.gov, "The purpose of this study is to test a new thyroid hormone preparation. The thyroid gland produces two thyroid hormones: mostly T4 and a smaller amount of T3. Thyroid hormone therapy for hypothyroidism or thyroid cancer is generally provided using levothyroxine, which is a synthetic form of T4. T4 is converted into the active hormone T3 in the circulation. Therefore, some researchers believe that T3 levels in T4-treated patients may be slightly lower than in individuals whose own thyroid gland is functioning normally. Symptoms of hypothyroidism have been suggested to occur because of this possible T3 deficiency, although this is controversial. Studies of T3, added to or substituted for T4 in traditional levothyroxine regimens, have generally not shown any benefit of T3. However, it is still possible that no benefit is seen because of the short duration of action or "half-life" of T3. This short-life makes it necessary to dose T3 twice or three times daily. Despite multiple daily doses of T3, T3 levels during its therapy tend to be troubled by peaks and troughs. These peaks can be associated with symptoms of excessive thyroid hormone levels. This study will look at TSH and thyroid hormone levels following a daily dose of a new preparation of T3 that may have longer duration of action than liothyronine. This preparation of T3 is called Thyromax® or BCT303. The investigators believe that steady levels of T3 will be seen after taking Thyromax®. The investigators believe that in patients with hypothyroidism use of Thyromax® in the correct dose will produce normal TSH levels, without producing symptoms of too much thyroid hormone. The goal of future studies is to test whether Thyromax® may be a potential treatment for hypothyroidism, by comparing it with traditional levothyroxine therapy."
Eligible patients will be:
•Hypothyroid, and taking levothyroxine (i.e, Synthroid, Levothroid, Tirosint, etc.)
•Able to make weekly in-person visits to Washington, D.C.
The study exclusion criteria include:
•Pregnant or nursing
•Have a chronic medical condition such as heart disease or any other chronic medical conditions such as lung disease (e.g. asthma), kidney disease (e.g. kidney failure), liver disease (e.g. hepatitis), diabetes, or cancer.Taking steroid medications such as estrogen, progesterone, estrogen or progesterone related medications, testosterone, or glucocorticoids
•Already taking T3
The study is being conducted at Georgetown University Hospital in Washington, DC. If you are interested in being recruited, the contact for the study is Jacqueline Jonklaas, M.D., Ph.D., 202 687 2012, email firstname.lastname@example.org. Please refer to Clinical Trials Identifier # NCT01800617 for the study. You may also want to follow Thyromax at their ThyroMax Facebook page.
Here is the trail details.
I wonder if there was a synthetic T3 would be more available, cost less?
I also wonder if a synthetic T3 would in effect cause the same sort of problems as synthetic T4?
The idea is a good one. that One pill to substitute multiple. But nothing is ever black and white!