DIM as a Treatment for Thyroid Disease

Early Phase 1

Terminated

• Conditions: Proliferative Thyroid Disease
• Interventions: Dietary Supplement: Diindolylmethane (DIM)

• Registration Number: NCT01846364
• Lead Sponsor: The New York Eye & Ear Infirmary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2013-04
• Study First Submitted: 2013-04-30
• Study First Submitted QC: 2013-04-30
• Last Update Submitted: 2013-04-30
• Study First Posted: 2013-05-03
• Last Update Posted: 2013-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Diindolylmethane (DIM)	Subjects with proliferative thyroid disease

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evidence of DIM's effect on estrogen metabolites, confirmed by plasma and urine analysis	after 30 days of DIM consumption

Trial Locations

Locations (1)

The New York Eye & Ear Infirmary; 🇺🇸 New York, New York, United States