Clinical trial NCT01846364: DIM as a Treatment for Thyroid Disease
Official title: Diindolymethane: Anti-proliferation Agent in Thyroid Disease-Non-surgical Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Proliferative Thyroid Disease
Keywords: Thyroid
DIM
Lead sponsor: The New York Eye & Ear Infirmary
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: 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
timeFrame: after 30 days of DIM consumption and 2 and 4 weeks after DIM consumption stopped
Secondary outcomes:
measure: Evidence of DIM's effect on estrogen metabolites, confirmed by plasma and urine analysis
timeFrame: after 30 days of DIM consumption
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Eye & Ear Infirmary
state: New York
Study officials:
affiliation: The New York Eye & Ear Infirmary
name: Stimson P. Schantz, MD
role: PRINCIPAL_INVESTIGATOR
References: