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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01551498
First received: March 5, 2012
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Dietary Supplement: Placebo
Placebo, as mint flavored lozenges, to be taken 3 times each day
Active Comparator: Anatabloc Supplement 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551498

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
Research Institute of Dallas
Dallas, Texas, United States, 75231
North Texas Endocrine Center
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

No publications provided by Rock Creek Pharmaceuticals, Inc.

Additional 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
Study First Received: March 5, 2012
Last Updated: February 7, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014