DIM as a Treatment for Thyroid Disease

• ClinicalTrials.gov Identifier: NCT01846364
• Recruitment Status: Terminated
• First Posted: May 3, 2013
• Last Update Posted: May 3, 2013
• Sponsor: The New York Eye & Ear Infirmary
• Information provided by (Responsible Party): Stimpson P. Schantz, The New York Eye & Ear Infirmary

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.

Condition or disease	Intervention/treatment	Phase
Proliferative Thyroid Disease	Dietary Supplement: Diindolylmethane (DIM)	Early Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Diindolymethane: Anti-proliferation Agent in Thyroid Disease-Non-surgical Protocol
• Study Start Date: November 2006
• Actual Primary Completion Date: August 2011
• Actual Study Completion Date: September 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: A; Subjects with proliferative thyroid disease	Dietary Supplement: Diindolylmethane (DIM); 300 mg of Bioresponse DIM (100mg/day of active DIM) a day for 30 days

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. Evidence of DIM's effect on estrogen metabolites, confirmed by plasma and urine analysis [ Time Frame: after 30 days of DIM consumption ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

The New York Eye & Ear Infirmary

New York, New York, United States, 10003

Sponsors and Collaborators

The New York Eye & Ear Infirmary

Investigators

• Principal Investigator: Stimson P. Schantz, MD; The New York Eye & Ear Infirmary

More Information

• Responsible Party: Stimpson P. Schantz, Principal Investigator, The New York Eye & Ear Infirmary
• ClinicalTrials.gov Identifier: NCT01846364
• Other Study ID Numbers: NYEEI06.33
• First Posted: May 3, 2013
• Last Update Posted: May 3, 2013
• Last Verified: April 2013

Keywords provided by Stimpson P. Schantz, The New York Eye & Ear Infirmary:

Thyroid; DIM

Additional relevant MeSH terms:

Thyroid Diseases; Endocrine System Diseases; 3,3'-diindolylmethane; Anticarcinogenic Agents; Protective Agents; Physiological Effects of Drugs; Antineoplastic Agents