Thyroiditis, AutoimmunePhase 2ASAPNCT01551498
Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention)
A Phase 2 study testing Anatabloc Supplement in people with Thyroiditis, Autoimmune, run by Rock Creek Pharmaceuticals, Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroiditis, Autoimmune
- What is being tested?
- Anatabloc Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2012to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults 18-70 years of age
- having positive antibodies against thyroid peroxidase
- having sonographic evidence consistent with a diagnosis of Hashimoto's thyroiditis
Who cannot join
- 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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Texas Diabetes & Endocrinology
Austin, Texas, 78731
New Jersey Physicians, LLC
Clifton, New Jersey, 07012
North Texas Endocrine Center
Dallas, Texas, 75231
Research Institute of Dallas
Dallas, Texas, 75231
Robert J. Becker, M.D., LTD
La Grange, Illinois, 60561
Texas Diabetes & Endocrinology
Round Rock, Texas, 78681
Associated Endocrinologists, P.C.
West Bloomfield, Michigan, 48322
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542
About this study
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
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.
Read the detailed description
This is a 5-visit, 12-week, double-blind, randomized, placebo-controlled, parallel-group study.
- Conditions
- Thyroiditis, Autoimmune
- Being tested
- Anatabloc Supplement, Placebo
- Keywords
- Hashimoto Disease, Thyroiditis
- Medical subject headings
- Thyroiditis, Autoimmune, Hashimoto Disease, Thyroiditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatabloc SupplementDietary supplement
Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day
PlaceboDietary supplement
Placebo, as mint flavored lozenges, to be taken 3 times each day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | subject takes one oral placebo lozenge, three times per day Receives: Dietary Supplement: Placebo |
| Anatabloc Supplement | Active comparator | subject takes one oral Supplement lozenge, three time per day Receives: Dietary Supplement: Anatabloc Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroiditis, AutoimmuneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rock Creek Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Varga, MD, Study director, Star Scientific, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551498
- Sponsor's protocol ID
- RCP-007
- Acronym
- ASAP
- Status last verified
- Oct 2015
- First submitted
- 5 Mar 2012
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24178792
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01551498
- Acronym / sponsor ID
- ASAP / RCP-007
- Conditions
- Thyroiditis, Autoimmune
- Keywords
- Hashimoto Disease, Thyroiditis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Rock Creek Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebosubject takes one oral placebo lozenge, three times per day |
| Anatabloc Supplement | Active comparator | Dietary Supplement: Anatabloc Supplementsubject takes one oral Supplement lozenge, three time per day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults 18-70 years of age
- having positive antibodies against thyroid peroxidase
- having sonographic evidence consistent with a diagnosis of Hashimoto's thyroiditis
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatabloc SupplementProduct, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day | Dietary supplement | Anatabloc Supplement |
| PlaceboPlacebo, as mint flavored lozenges, to be taken 3 times each day | Dietary supplement | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Derived from this study: PubMed 24178792Schmeltz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Varga, MD study director
Star Scientific, Inc
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anatabloc Supplement in people with Thyroiditis, Autoimmune, run by Rock Creek Pharmaceuticals, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of subjects experiencing adverse effects as a measure of safety (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01551498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.