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

October 29, 2015 updated by: Rock Creek Pharmaceuticals, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute, Inc.
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, P.A.
    • Illinois
      • La Grange, Illinois, United States, 60561
        • Robert J. Becker, M.D., LTD
    • Michigan
      • West Bloomfield, Michigan, United States, 48322
        • Associated Endocrinologists, P.C.
    • New Jersey
      • Clifton, New Jersey, United States, 07012
        • New Jersey Physicians, LLC
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Diabetes & Endocrinology
      • Dallas, Texas, United States, 75231
        • Research Institute Of Dallas
      • Dallas, Texas, United States, 75231
        • North Texas Endocrine Center
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes & Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rock Creek Pharmaceuticals, Inc.

Investigators

  • Study Director: Maria Varga, MD, Star Scientific, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimate)

March 12, 2012

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 29, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCP-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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