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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Metabolic Research Institute, Inc., West Palm Beach, Florida, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anatabloc Supplement

Dietary Supplement

Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day

Placebo

Dietary Supplement

Placebo, as mint flavored lozenges, to be taken 3 times each day

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Rock Creek Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Acronym: ASAP

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Mar 12, 2012
Registry last updated: Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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