Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention) (ASAP)
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| ClinicalTrials.gov Identifier: NCT01551498 |
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Recruitment Status :
Completed
First Posted : March 12, 2012
Last Update Posted : November 2, 2015
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Sponsor:
Rock Creek Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.
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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 |
This is a 5-visit, 12-week, double-blind, randomized, placebo-controlled, parallel-group study.
| 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
Genetics Home Reference related topics:
Hashimoto thyroiditis
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
subject takes one oral placebo lozenge, three times per day
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Dietary Supplement: Placebo
Placebo, as mint flavored lozenges, to be taken 3 times each day |
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Active Comparator: Anatabloc Supplement
subject takes one oral Supplement lozenge, three time per day
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Dietary Supplement: Anatabloc Supplement
Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day |
Primary Outcome Measures :
- 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 :
- 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
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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
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
| 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
| Study Director: | Maria Varga, MD | Star Scientific, Inc |
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 |
| First Posted: | March 12, 2012 Key Record Dates |
| Last Update Posted: | November 2, 2015 |
| Last Verified: | October 2015 |
Keywords provided by Rock Creek Pharmaceuticals, Inc.:
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Hashimoto Disease Thyroiditis |
Additional relevant MeSH terms:
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Thyroiditis Thyroiditis, Autoimmune Thyroid Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |