DIM as a Treatment for Thyroid Disease

NCT ID: NCT01846364

Last Updated: 2013-05-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2011-09-30

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.

Conditions

Proliferative Thyroid Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

A

Subjects with proliferative thyroid disease

Group Type: EXPERIMENTAL

Diindolylmethane (DIM)

Intervention Type: DIETARY_SUPPLEMENT

300 mg of Bioresponse DIM (100mg/day of active DIM) a day for 30 days

Interventions

Diindolylmethane (DIM)

300 mg of Bioresponse DIM (100mg/day of active DIM) a day for 30 days

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The New York Eye & Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Stimpson P. Schantz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stimson P. Schantz, MD

Role: PRINCIPAL_INVESTIGATOR

The New York Eye & Ear Infirmary

Locations

The New York Eye & Ear Infirmary

New York, New York, United States

Countries

United States

Other Identifiers

NYEEI06.33

Identifier Type: -

Identifier Source: org_study_id