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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
165
Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day
Placebo, as mint flavored lozenges, to be taken 3 times each day
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States
Robert J. Becker, M.D., LTD
La Grange, Illinois, United States
Associated Endocrinologists, P.C.
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
Time frame: 3 months
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
Time frame: 3 months
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West Bloomfield, Michigan, United States
New Jersey Physicians, LLC
Clifton, New Jersey, United States
Texas Diabetes & Endocrinology
Austin, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
Research Institute of Dallas
Dallas, Texas, United States
Texas Diabetes & Endocrinology
Round Rock, Texas, United States