Primary Hypothyroidism. Clinical Trial
— DTEOfficial title:
Desiccated Thyroid Extract Compared to Levothyroxine in the Treatment of Hypothyroidism: A Randomized, Double-blind, Crossover Study.
Our hypothesis is that hypothyroid patients on DTE may have a decrease in symptoms, an improvement of cognitive function, and an increase in sense of well-being/ quality of life equivalently compared with L-T4.
| Status | Unknown status |
| Enrollment | 180 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Patients will be between the ages of 18 to 65 and will have been on levothyroxine for primary hypothyroidism for at least 6 months. Exclusion Criteria: - Patients will be excluded if they have the following problems: pregnancy, 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, chemotherapy for cancer, iron supplement more than 325mg per day, carafate/ proton pump inhibitor use, cholestyramine use, and those with recent PCS orders who are expected to move out of the geographic area, age less than 18 years old or older than 65 years old. - Patients scheduled for deployment will be excluded. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
| United States | Walter Reed National Military Medical Center, Endocrinology | Bethesda | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Walter Reed National Military Medical Center |
United States,
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* Note: There are 34 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Beck Depression Index | The BDI is a self-rating scale of 21 items, in which scores of 10 or less indicate normal mood variation and scores of 11 or more reflect increasing levels of depression. Clinically important depression is associated with scores of 20 or more. | 4 months | |
| Other | General health questionnaire-12 | General health questionnaire - consists of 12 quality of life questions. | 4 months | |
| Other | Clinical preference | At the completion of the study, each patient will be asked which treatment (the first or the second) he or she preferred. | 4 months | |
| Primary | thyroid-symptom questionnaire | Thyroid Symptom Questionnaire, a health-related quality-of-life questionnaire, that consists of 12 questions, presented in the same format as the GHQ-12, that asked patients how they felt over the last three months. | 4 months | |
| Primary | Wechsler Memory Scale-Version IV (WMS-IV) | The Wechsler Memory Scale-Version IV (WMS-IV) included auditory memory index, visual memory index, visual working memory index, immediate memory index and delayed memory index. | 4 months | |
| Secondary | Biochemical measures | Biochemical testing consisting of serum TSH, free T4, total T4, total T3, T3 resin uptake, sex hormone binding globulin (SHBG), and a lipid panel. | 4 months |