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

Rock Creek Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Thyroiditis, Autoimmune

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Anatabloc Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT01551498

RCP-007

Details and patient eligibility

About

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.

Full description

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

Enrollment: 165 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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165 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

subject takes one oral placebo lozenge, three times per day

Treatment:

Dietary Supplement: Placebo

Anatabloc Supplement

Active Comparator group

Description:

subject takes one oral Supplement lozenge, three time per day

Treatment:

Dietary Supplement: Anatabloc Supplement