search
Back to results

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

Primary Purpose

Thyroiditis, Autoimmune

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anatabloc Supplement
Placebo
Sponsored by
Rock Creek Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroiditis, Autoimmune focused on measuring Hashimoto Disease, Thyroiditis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Metabolic Research Institute, Inc.
  • Florida Medical Clinic, P.A.
  • Robert J. Becker, M.D., LTD
  • Associated Endocrinologists, P.C.
  • New Jersey Physicians, LLC
  • Texas Diabetes & Endocrinology
  • North Texas Endocrine Center
  • Research Institute of Dallas
  • Texas Diabetes & Endocrinology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Anatabloc Supplement

Arm Description

subject takes one oral placebo lozenge, three times per day

subject takes one oral Supplement lozenge, three time per day

Outcomes

Primary Outcome Measures

Numbers of subjects experiencing adverse effects as a measure of safety
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
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

Full Information

First Posted
March 5, 2012
Last Updated
October 29, 2015
Sponsor
Rock Creek Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01551498
Brief Title
Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention)
Acronym
ASAP
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 Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rock Creek Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroiditis, Autoimmune
Keywords
Hashimoto Disease, Thyroiditis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
subject takes one oral placebo lozenge, three times per day
Arm Title
Anatabloc Supplement
Arm Type
Active Comparator
Arm Description
subject takes one oral Supplement lozenge, three time per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Anatabloc Supplement
Intervention Description
Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo, as mint flavored lozenges, to be taken 3 times each day
Primary Outcome Measure Information:
Title
Numbers of subjects experiencing adverse effects as a measure of safety
Description
Collected data on the numbers and types of any adverse effects related to the use of Anatabloc by subjects
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Varga, MD
Organizational Affiliation
Star Scientific, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Metabolic Research Institute, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Florida Medical Clinic, P.A.
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Robert J. Becker, M.D., LTD
City
La Grange
State/Province
Illinois
ZIP/Postal Code
60561
Country
United States
Facility Name
Associated Endocrinologists, P.C.
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
New Jersey Physicians, LLC
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07012
Country
United States
Facility Name
Texas Diabetes & Endocrinology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
North Texas Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Diabetes & Endocrinology
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24178792
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs