DIM as a Treatment for Thyroid Disease

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StatusPrekinuta

Sponzori

The New York Eye & Ear Infirmary

KLINIČKO ISPITIVANJE: NCT01846364

BioSeek: nct01846364

Ključne riječi

Sažetak

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.

Datumi

Posljednja provjera:	03/31/2013
Prvo podneseno:	04/29/2013
Predviđena prijava poslana:	04/29/2013
Prvo objavljeno:	05/02/2013
Posljednje ažuriranje poslano:	04/29/2013
Posljednje ažuriranje objavljeno:	05/02/2013
Stvarni datum početka studija:	10/31/2006
Procijenjeni datum primarnog završetka:	07/31/2011
Procijenjeni datum završetka studije:	08/31/2011

Stanje ili bolest

Proliferative Thyroid Disease

Intervencija / liječenje

Dietary Supplement: A

Faza

Grupe ruku

Ruka	Intervencija / liječenje
Experimental: A Subjects with proliferative thyroid disease	Dietary Supplement: A 300 mg of Bioresponse DIM (100mg/day of active DIM) a day for 30 days

Kriterij prihvatljivosti

Dobni uvjeti za studiranje	18 Years Do 18 Years
Spolovi koji ispunjavaju uvjete za studij	All
Prihvaća zdrave volontere	Da
Kriteriji	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.

Ishod

Primarne mjere ishoda

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]

Sekundarne mjere ishoda

1. Evidence of DIM's effect on estrogen metabolites, confirmed by plasma and urine analysis [after 30 days of DIM consumption]

DIM as a Treatment for Thyroid Disease

Ključne riječi

rak

diindolylmethane

kupus

zelje

antikancerogeno