NCT01551498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

10 months

First QC Date

March 5, 2012

Last Update Submit

October 29, 2015

Conditions

Thyroiditis, Autoimmune

Keywords

Hashimoto DiseaseThyroiditis

Outcome Measures

Primary Outcomes (1)

  • Numbers of subjects experiencing adverse effects as a measure of safety

    Collected data on the numbers and types of any adverse effects related to the use of Anatabloc by subjects

    3 months

Secondary Outcomes (1)

  • 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

    3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

subject takes one oral placebo lozenge, three times per day

Dietary Supplement: Placebo

Anatabloc Supplement

ACTIVE COMPARATOR

subject takes one oral Supplement lozenge, three time per day

Dietary Supplement: Anatabloc Supplement

Interventions

Anatabloc SupplementDIETARY_SUPPLEMENT

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

Anatabloc Supplement
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults 18-70 years of age
  • having positive antibodies against thyroid peroxidase
  • having sonographic evidence consistent with a diagnosis of Hashimoto's thyroiditis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States

Location

Florida Medical Clinic, P.A.

Zephyrhills, Florida, 33542, United States

Location

Robert J. Becker, M.D., LTD

La Grange, Illinois, 60561, United States

Location

Associated Endocrinologists, P.C.

West Bloomfield, Michigan, 48322, United States

Location

New Jersey Physicians, LLC

Clifton, New Jersey, 07012, United States

Location

Texas Diabetes & Endocrinology

Austin, Texas, 78731, United States

Location

North Texas Endocrine Center

Dallas, Texas, 75231, United States

Location

Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Texas Diabetes & Endocrinology

Round Rock, Texas, 78681, United States

Location

Related Publications (1)

  • 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.

    PMID: 24178792DERIVED

MeSH Terms

Conditions

Thyroiditis, AutoimmuneHashimoto DiseaseThyroiditis

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Maria Varga, MD

    Star Scientific, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 12, 2012

Study Start

March 1, 2012

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

November 2, 2015

Record last verified: 2015-10

Locations

US(9)