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This is a study to evaluate the safety, tolerability, and potential effects of Anatabloc dietary supplementation on antithyroid autoantibodies, thyroid structure, and thyroid function in subjects with autoimmune thyroiditis.
This is a 5-visit, 12-week, double-blind, randomized, placebo-controlled, parallel-group study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | subject takes one oral placebo lozenge, three times per day |
|
| Anatabloc Supplement | Active Comparator | subject takes one oral Supplement lozenge, three time per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anatabloc Supplement | Dietary Supplement | Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of subjects experiencing adverse effects as a measure of safety | Collected data on the numbers and types of any adverse effects related to the use of Anatabloc by subjects | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measured changes in markers of autoimmune thyroiditis: changes in blood levels of anti-thyroid auto-antibodies, and changes in the volume and vascularization of the thyroid | To determine if dietary supplementation with Anatabloc has an effect on antithyroid autoantibody levels, thyroid structure, and/or thyroid function in subjects with autoimmune thyroiditis | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Varga, MD | Star Scientific, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metabolic Research Institute, Inc. | West Palm Beach | Florida | 33401 | United States | ||
| Florida Medical Clinic, P.A. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24178792 | Derived | Schmeltz LR, Blevins TC, Aronoff SL, Ozer K, Leffert JD, Goldberg MA, Horowitz BS, Bertenshaw RH, Troya P, Cohen AE, Lanier RK, Wright C 4th. Anatabine supplementation decreases thyroglobulin antibodies in patients with chronic lymphocytic autoimmune (Hashimoto's) thyroiditis: a randomized controlled clinical trial. J Clin Endocrinol Metab. 2014 Jan;99(1):E137-42. doi: 10.1210/jc.2013-2951. Epub 2013 Dec 20. |
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| Placebo | Dietary Supplement | Placebo, as mint flavored lozenges, to be taken 3 times each day |
|
| Zephyrhills |
| Florida |
| 33542 |
| United States |
| Robert J. Becker, M.D., LTD | La Grange | Illinois | 60561 | United States |
| Associated Endocrinologists, P.C. | West Bloomfield | Michigan | 48322 | United States |
| New Jersey Physicians, LLC | Clifton | New Jersey | 07012 | United States |
| Texas Diabetes & Endocrinology | Austin | Texas | 78731 | United States |
| North Texas Endocrine Center | Dallas | Texas | 75231 | United States |
| Research Institute of Dallas | Dallas | Texas | 75231 | United States |
| Texas Diabetes & Endocrinology | Round Rock | Texas | 78681 | United States |
| ID | Term |
|---|---|
| D013967 | Thyroiditis, Autoimmune |
| D050031 | Hashimoto Disease |
| D013966 | Thyroiditis |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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