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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Rock Creek Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT01551498

First received: March 5, 2012

Last updated: October 23, 2014

Last verified: October 2014

History of Changes

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:

Genetics Home Reference related topics: Hashimoto thyroiditis

MedlinePlus related topics: Dietary Supplements Thyroid Diseases

Genetic and Rare Diseases Information Center resources: Lymphomatous Thyroiditis

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

More Information

No publications provided by Rock Creek Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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:	October 23, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Rock Creek Pharmaceuticals, Inc.:


Hashimoto Disease Thyroiditis

Additional relevant MeSH terms:


Thyroiditis Thyroiditis, Autoimmune Autoimmune Diseases	Endocrine System Diseases Immune System Diseases Thyroid Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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