DIM as a Treatment for Thyroid Disease

April 30, 2013 updated by: Stimpson P. Schantz, The New York Eye & Ear Infirmary

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • The New York Eye & Ear Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
after 30 days of DIM consumption and 2 and 4 weeks after DIM consumption stopped

Secondary Outcome Measures

Outcome Measure
Time Frame
Evidence of DIM's effect on estrogen metabolites, confirmed by plasma and urine analysis
Time Frame: after 30 days of DIM consumption
after 30 days of DIM consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The New York Eye & Ear Infirmary

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

April 30, 2013

First Submitted That Met QC Criteria

April 30, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

April 30, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYEEI06.33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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