Back to resultsDIM as a Treatment for Thyroid Disease
Primary Purpose
Proliferative Thyroid Disease
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Diindolylmethane (DIM)
Sponsored by
About this trial
This is an interventional basic science trial for Proliferative Thyroid Disease focused on measuring Thyroid, DIM
Eligibility Criteria
Inclusion Criteria:
- Adults diagnosed with abnormalities of the thyroid gland suspicious for benign adenoma, or goiterous changes.
Exclusion Criteria:
- 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.
Sites / Locations
- The New York Eye & Ear Infirmary
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Subjects with proliferative thyroid disease
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Evidence of DIM's effect on estrogen metabolites, confirmed by plasma and urine analysis
Full Information
NCT ID
NCT01846364
First Posted
April 30, 2013
Last Updated
April 30, 2013
Sponsor
The New York Eye & Ear Infirmary
1. Study Identification
Unique Protocol Identification Number
NCT01846364
Brief Title
DIM as a Treatment for Thyroid Disease
Official Title
Diindolymethane: Anti-proliferation Agent in Thyroid Disease-Non-surgical Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of sufficient enrollment
Study Start Date
November 2006 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The New York Eye & Ear Infirmary
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Thyroid Disease
Keywords
Thyroid, DIM
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Subjects with proliferative thyroid disease
Intervention Type
Dietary Supplement
Intervention Name(s)
Diindolylmethane (DIM)
Intervention Description
300 mg of Bioresponse DIM (100mg/day of active DIM) a day for 30 days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Evidence of DIM's effect on estrogen metabolites, confirmed by plasma and urine analysis
Time Frame
after 30 days of DIM consumption
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults diagnosed with abnormalities of the thyroid gland suspicious for benign adenoma, or goiterous changes.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stimson P. Schantz, MD
Organizational Affiliation
The New York Eye & Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
The New York Eye & Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Learn more about this trial
DIM as a Treatment for Thyroid Disease
We'll reach out to this number within 24 hrs