DIM as a Treatment for Thyroid Disease

NCT01846364 | Terminated Early Phase 1

• 1 other identifier: NYEEI06.33
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Keywords

Thyroid; DIM

Outcome Measures

Primary Outcomes (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

  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

  after 30 days of DIM consumption

Study Arms (1)

A

EXPERIMENTAL

Subjects with proliferative thyroid disease

Dietary Supplement: Diindolylmethane (DIM)

Interventions

Diindolylmethane (DIM) DIETARY_SUPPLEMENT

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

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults diagnosed with abnormalities of the thyroid gland suspicious for benign adenoma, or goiterous changes.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The New York Eye & Ear Infirmary: lead

Study Sites (1)

The New York Eye & Ear Infirmary

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Thyroid Diseases

Interventions

3,3'-diindolylmethane

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Stimson P. Schantz, MD

  The New York Eye & Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 3, 2013
• Study Start: November 1, 2006
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 3, 2013

Record last verified: 2013-04

Locations

US (1)