Clinical trial NCT01551498: Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention)
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroiditis, Autoimmune
Keywords: Hashimoto Disease
Thyroiditis
Lead sponsor: Rock Creek Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-12
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numbers of subjects experiencing adverse effects as a measure of safety
timeFrame: 3 months
Secondary outcomes:
measure: 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
timeFrame: 3 months
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: La Grange
country: United States
facility: Robert J. Becker, M.D., LTD
state: Illinois
city: West Bloomfield
country: United States
facility: Associated Endocrinologists, P.C.
state: Michigan
city: Clifton
country: United States
facility: New Jersey Physicians, LLC
state: New Jersey
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology
state: Texas
city: Dallas
country: United States
facility: North Texas Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology
state: Texas
Study officials:
affiliation: Star Scientific, Inc
name: Maria Varga, MD
role: STUDY_DIRECTOR
References:
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.