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

Sponsor

Rock Creek Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01551498

Collaborator

(none)

165

Enrollment

Locations

Arms

11.1

Duration (Months)

18.3

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Mar 1, 2012

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

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

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

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Metabolic Research Institute, Inc.	West Palm Beach	Florida	United States	33401
2	Florida Medical Clinic, P.A.	Zephyrhills	Florida	United States	33542
3	Robert J. Becker, M.D., LTD	La Grange	Illinois	United States	60561
4	Associated Endocrinologists, P.C.	West Bloomfield	Michigan	United States	48322
5	New Jersey Physicians, LLC	Clifton	New Jersey	United States	07012
6	Texas Diabetes & Endocrinology	Austin	Texas	United States	78731
7	North Texas Endocrine Center	Dallas	Texas	United States	75231
8	Research Institute of Dallas	Dallas	Texas	United States	75231
9	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rock Creek Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT01551498

Other Study ID Numbers:

RCP-007

First Posted:

Mar 12, 2012

Last Update Posted:

Nov 1, 2015

Last Verified:

Oct 1, 2015

Keywords provided by Rock Creek Pharmaceuticals, Inc.

Hashimoto Disease

Thyroiditis

Additional relevant MeSH terms:

Thyroiditis

Thyroiditis, Autoimmune

Study Results

No Results Posted as of Nov 1, 2015