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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 12, 2012
Last Update Posted: November 2, 2015
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.
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.
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 Intervention Phase
Thyroiditis, Autoimmune Dietary Supplement: Anatabloc Supplement Dietary Supplement: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Rock Creek Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 165
Study Start Date: March 2012
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551498

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.
Study Director: Maria Varga, MD Star Scientific, Inc
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01551498     History of Changes
Other Study ID Numbers: RCP-007
First Submitted: March 5, 2012
First Posted: March 12, 2012
Last Update Posted: November 2, 2015
Last Verified: October 2015

Keywords provided by Rock Creek Pharmaceuticals, Inc.:
Hashimoto Disease

Additional relevant MeSH terms:
Thyroiditis, Autoimmune
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases