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

Phase 2

Completed

• Conditions: Thyroiditis, Autoimmune
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Anatabloc Supplement

• Registration Number: NCT01551498
• Lead Sponsor: Rock Creek Pharmaceuticals, Inc.

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-12
• Primary Completion: 2013-01
• Study Completion: 2013-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	subject takes one oral placebo lozenge, three times per day
Anatabloc Supplement	Anatabloc Supplement	subject takes one oral Supplement lozenge, three time per day

Primary Outcome Measures

Name	Time	Method
Numbers of subjects experiencing adverse effects as a measure of safety	3 months	Collected data on the numbers and types of any adverse effects related to the use of Anatabloc by subjects

Secondary Outcome Measures

Name	Time	Method
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	3 months	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

Trial Locations

Locations (8)

Metabolic Research Institute, Inc.; 🇺🇸 West Palm Beach, Florida, United States

Florida Medical Clinic, P.A.; 🇺🇸 Zephyrhills, Florida, United States

Associated Endocrinologists, P.C.; 🇺🇸 West Bloomfield, Michigan, United States

Robert J. Becker, M.D., LTD; 🇺🇸 La Grange, Illinois, United States

New Jersey Physicians, LLC; 🇺🇸 Clifton, New Jersey, United States

Texas Diabetes & Endocrinology; 🇺🇸 Round Rock, Texas, United States

North Texas Endocrine Center; 🇺🇸 Dallas, Texas, United States

Research Institute of Dallas; 🇺🇸 Dallas, Texas, United States