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

Thyroiditis, Autoimmune Clinical Trial

— ASAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551498
• Other study ID #: RCP-007
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2012
• Last updated: October 29, 2015
• Start date: March 2012
• Est. completion date: February 2013

Study information

• Verified date: October 2015
• Source: Rock Creek Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroiditis
• Thyroiditis, Autoimmune

Intervention

Dietary Supplement:
• Anatabloc Supplement
Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day
• Placebo
Placebo, as mint flavored lozenges, to be taken 3 times each day

Locations

Country	Name	City	State
United States	Texas Diabetes & Endocrinology	Austin	Texas
United States	New Jersey Physicians, LLC	Clifton	New Jersey
United States	North Texas Endocrine Center	Dallas	Texas
United States	Research Institute of Dallas	Dallas	Texas
United States	Robert J. Becker, M.D., LTD	La Grange	Illinois
United States	Texas Diabetes & Endocrinology	Round Rock	Texas
United States	Associated Endocrinologists, P.C.	West Bloomfield	Michigan
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida
United States	Florida Medical Clinic, P.A.	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Rock Creek Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No