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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-02-28

Brief Summary

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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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Detailed Description

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

Conditions

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Thyroiditis, Autoimmune

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

subject takes one oral placebo lozenge, three times per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Anatabloc Supplement

subject takes one oral Supplement lozenge, three time per day

Group Type ACTIVE_COMPARATOR

Anatabloc Supplement

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Anatabloc Supplement

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No