Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention)
This study has been completed.
Sponsor:
Rock Creek Pharmaceuticals, Inc.
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
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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
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
| 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 June 13, 2013