Proliferative Thyroid DiseaseEarly Phase 1NCT01846364
DIM as a Treatment for Thyroid Disease
A Early Phase 1 study testing Diindolylmethane (DIM) in people with Proliferative Thyroid Disease, run by The New York Eye & Ear Infirmary at 1 site in United States.
Trial summary
Diindolylmethane (DIM), a dietary supplement, found naturally in cruciferous vegetables (such as cabbage, cauliflower, broccoli, \& Brussels sprouts) has been studied extensively in recent years for its anti-cancer effects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Proliferative Thyroid Disease
- What is being tested?
- Diindolylmethane (DIM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Sep 2011
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults diagnosed with abnormalities of the thyroid gland suspicious for benign adenoma, or goiterous changes.
Who cannot join
- Patients who are pregnant, attempting to conceive, or lactating will be excluded due to possible deleterious effects of treatment on fetus/infant. Patients taking oral contraceptives, estrogen therapy, tamoxifin or those with a history of breast cancer will be excluded. Patients with liver disease and those taking statins for hypercholesterolemia will also be excluded to decrease the potential for possible liver toxicity. Any patient with elevated liver enzymes on pretreatment blood screening will be excluded from study participation. Patients with serious systemic diseases such as renal failure, diabetes, blood dyscrasia, coagulopathy, and non-optimized cardiopulmonary disease will be excluded due to the possibility of confounding blood tests screening for toxicity.
Trial locations and contacts
1 site in 1 country.
United States1 site
The New York Eye & Ear Infirmary
New York, New York, 10003
About this study
Official title: Diindolymethane: Anti-proliferation Agent in Thyroid Disease-Non-surgical Protocol
Diindolylmethane (DIM), a dietary supplement, found naturally in cruciferous vegetables (such as cabbage, cauliflower, broccoli, \& Brussels sprouts) has been studied extensively in recent years for its anti-cancer effects. DIM has been shown to exert control over cancer cell growth in breast, uterine, cervical, ovarian, and colon cancer.
To date no human study has been published regarding the bioavailability of DIM in thyroid tissue or its effects in proliferative thyroid disease. Our previous study attempted to elucidate DIM's promotion of anti-proliferative estrogen metabolites in proliferative thyroid disease and ascertain its uptake in thyroid tissue. DIM has been shown to concentrate in the thyroid gland. Furthermore, thyroid volumes have been seen to decrease subjectively.
This study would continue our attempt to elucidate DIM's promotion of anti-proliferative estrogen metabolites in proliferative thyroid disease.
- Conditions
- Proliferative Thyroid Disease
- Being tested
- Diindolylmethane (DIM)
- Keywords
- Thyroid, DIM
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diindolylmethane (DIM)Dietary supplement
300 mg of Bioresponse DIM (100mg/day of active DIM) a day for 30 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects with proliferative thyroid disease Receives: Dietary Supplement: Diindolylmethane (DIM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of objective and quantifiable changes in thyroid size as a resalt of the oral administration of DIM, confirmed by pre- and post- DIM treatment ultrasounds
Measured: after 30 days of DIM consumption and 2 and 4 weeks after DIM consumption stopped
Secondary outcomes (1)
Evidence of DIM's effect on estrogen metabolites, confirmed by plasma and urine analysis
Measured: after 30 days of DIM consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startNov 2006
- Primary completionAug 2011
- Study completionSep 2011
Why it stopped: Lack of sufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Thyroid DiseaseStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New York Eye & Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stimpson P. Schantz, The New York Eye & Ear Infirmary
- Investigators
- Stimson P. Schantz, MD, Principal investigator, The New York Eye & Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846364
- Sponsor's protocol ID
- NYEEI06.33
- Status last verified
- Apr 2013
- First submitted
- 30 Apr 2013
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diindolymethane: Anti-proliferation Agent in Thyroid Disease-Non-surgical Protocol
- ClinicalTrials.gov ID
- NCT01846364
- Acronym / sponsor ID
- NYEEI06.33
- Conditions
- Proliferative Thyroid Disease
- Keywords
- Thyroid, DIM
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of sufficient enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The New York Eye & Ear InfirmaryUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 May 2013 (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.
Diindolylmethane (DIM), a dietary supplement, found naturally in cruciferous vegetables (such as cabbage, cauliflower, broccoli, \& Brussels sprouts) has been studied extensively in recent years for its anti-cancer effects. DIM has been shown to exert control over cancer cell growth in breast, uterine, cervical, ovarian, and colon cancer.
To date no human study has been published regarding the bioavailability of DIM in thyroid tissue or its effects in proliferative thyroid disease. Our previous study attempted to elucidate DIM's promotion of anti-proliferative estrogen metabolites in proliferative thyroid disease and ascertain its uptake in thyroid tissue. DIM has been shown to concentrate in the thyroid gland. Furthermore, thyroid volumes have been seen to decrease subjectively.
This study would continue our attempt to elucidate DIM's promotion of anti-proliferative estrogen metabolites in proliferative thyroid disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: Diindolylmethane (DIM)Subjects with proliferative thyroid disease |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults diagnosed with abnormalities of the thyroid gland suspicious for benign adenoma, or goiterous changes.
Key exclusion criteria (1 listed)
- Patients who are pregnant, attempting to conceive, or lactating will be excluded due to possible deleterious effects of treatment on fetus/infant. Patients taking oral contraceptives, estrogen therapy, tamoxifin or those with a history of breast cancer will be excluded. Patients with liver disease and those taking statins for hypercholesterolemia will also be excluded to decrease the potential for possible liver toxicity. Any patient with elevated liver enzymes on pretreatment blood screening will be excluded from study participation. Patients with serious systemic diseases such as renal failure, diabetes, blood dyscrasia, coagulopathy, and non-optimized cardiopulmonary disease will be excluded due to the possibility of confounding blood tests screening for toxicity.
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 |
|---|---|---|
| Diindolylmethane (DIM)300 mg of Bioresponse DIM (100mg/day of active DIM) a day for 30 days | Dietary supplement | A |
Primary outcome
Evidence of objective and quantifiable changes in thyroid size as a resalt of the oral administration of DIM, confirmed by pre- and post- DIM treatment ultrasounds
Time frame: after 30 days of DIM consumption and 2 and 4 weeks after DIM consumption stopped
1 secondary outcome
Evidence of DIM's effect on estrogen metabolites, confirmed by plasma and urine analysis
Time frame: after 30 days of DIM consumption
Results and safety
The study was stopped early (reason given: Lack of sufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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.
Stimson P. Schantz, MD principal investigator
The New York Eye & Ear Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Diindolylmethane (DIM) in people with Proliferative Thyroid Disease, run by The New York Eye & Ear Infirmary at 1 site 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Lack of sufficient enrollment). Results are not available in the source record.
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?
Evidence of objective and quantifiable changes in thyroid size as a resalt of the oral administration of DIM, confirmed by pre- and post- DIM treatment ultrasounds (time frame: after 30 days of DIM consumption and 2 and 4 weeks after DIM consumption stopped). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2013.