Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention)

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
This is a 5-visit, 12-week, double-blind, randomized, placebo-controlled, parallel-group study.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Potential Effects of the Dietary Supplement Anatabloc on Antithyroid Autoantibodies and Thyroid Function in Autoimmune Thyroiditis

Conditions
-----------------
Thyroiditis, Autoimmune

Intervention / Treatment
-----------------
* Dietary Supplement: Anatabloc Supplement
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults 18-70 years of age having positive antibodies against thyroid peroxidase having sonographic evidence consistent with a diagnosis of Hashimoto's thyroiditis Exclusion Criteria: having evidence of end-stage thyroiditis being a current smoker or smokeless tobacco user be taking systemic glucocorticoids, interferon-alpha, anti-CD20 antibody, or anti-CTLA-4 antibody be taking any medication for treatment of autoimmune thyroiditis other than L-thyroxine or equivalent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>subject takes one oral placebo lozenge, three times per day | Dietary Supplement: Placebo<br>* Placebo, as mint flavored lozenges, to be taken 3 times each day<br>|
| Active Comparator: Anatabloc Supplement<br>subject takes one oral Supplement lozenge, three time per day | Dietary Supplement: Anatabloc Supplement<br>* Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hashimoto Disease, Thyroiditis