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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01551498
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : November 2, 2015
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.

March 5, 2012
March 12, 2012
November 2, 2015
March 2012
January 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01551498 on Archive Site
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
Same as current
Not Provided
Not Provided
Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention)
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
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.
This is a 5-visit, 12-week, double-blind, randomized, placebo-controlled, parallel-group study.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Thyroiditis, Autoimmune
  • Dietary Supplement: Anatabloc Supplement
    Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day
  • Dietary Supplement: Placebo
    Placebo, as mint flavored lozenges, to be taken 3 times each day
  • Placebo Comparator: Placebo
    subject takes one oral placebo lozenge, three times per day
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: Anatabloc Supplement
    subject takes one oral Supplement lozenge, three time per day
    Intervention: Dietary Supplement: Anatabloc Supplement
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2013
January 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Rock Creek Pharmaceuticals, Inc.
Rock Creek Pharmaceuticals, Inc.
Not Provided
Study Director: Maria Varga, MD Star Scientific, Inc
Rock Creek Pharmaceuticals, Inc.
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP