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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Thyroiditis, Autoimmune	Dietary Supplement: Anatabloc Supplement; Dietary Supplement: Placebo	Phase 2

Detailed Description:

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

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	165 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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
Study Start Date :	March 2012
Actual Primary Completion Date :	January 2013
Actual Study Completion Date :	February 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: Placebo; subject takes one oral placebo lozenge, three times per day	Dietary Supplement: Placebo; Placebo, as mint flavored lozenges, to be taken 3 times each day
Active Comparator: Anatabloc Supplement; subject takes one oral Supplement lozenge, three time per day	Dietary Supplement: Anatabloc Supplement; Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Numbers of subjects experiencing adverse effects as a measure of safety [ Time Frame: 3 months ]
   Collected data on the numbers and types of any adverse effects related to the use of Anatabloc by subjects

Secondary Outcome Measures :

1. 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 [ Time Frame: 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Florida
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States, 33401
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States, 33542
United States, Illinois
Robert J. Becker, M.D., LTD
La Grange, Illinois, United States, 60561
United States, Michigan
Associated Endocrinologists, P.C.
West Bloomfield, Michigan, United States, 48322
United States, New Jersey
New Jersey Physicians, LLC
Clifton, New Jersey, United States, 07012
United States, Texas
Texas Diabetes & Endocrinology
Austin, Texas, United States, 78731
North Texas Endocrine Center
Dallas, Texas, United States, 75231
Research Institute of Dallas
Dallas, Texas, United States, 75231
Texas Diabetes & Endocrinology
Round Rock, Texas, United States, 78681

Sponsors and Collaborators

Rock Creek Pharmaceuticals, Inc.

Investigators

Study Director:	Maria Varga, MD	Star Scientific, Inc

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01551498 History of Changes
Other Study ID Numbers:	RCP-007
First Posted:	March 12, 2012
Last Update Posted:	November 2, 2015
Last Verified:	October 2015

Keywords provided by Rock Creek Pharmaceuticals, Inc.:

Hashimoto Disease; Thyroiditis

Additional relevant MeSH terms:

Thyroiditis; Thyroiditis, Autoimmune; Thyroid Diseases	Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases