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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.
 
ClinicalTrials.gov Identifier: NCT01551498
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : November 1, 2015
Sponsor:
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.

Study Description
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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 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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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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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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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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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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


Locations
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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
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Study Director: Maria Varga, MD Star Scientific, Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01551498    
Other Study ID Numbers: RCP-007
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: November 1, 2015
Last Verified: October 2015
Keywords provided by Rock Creek Pharmaceuticals, Inc.:
Hashimoto Disease
Thyroiditis
Additional relevant MeSH terms:
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Thyroiditis
Thyroiditis, Autoimmune
Thyroid Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases