DIM as a Treatment for Thyroid Disease

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Sponsorer

The New York Eye & Ear Infirmary

KLINISK PRÖVNING: NCT01846364

BioSeek: nct01846364

Nyckelord

Abstrakt

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.

Datum

Senast verifierad:	03/31/2013
Först skickat:	04/29/2013
Beräknad anmälan inlämnad:	04/29/2013
Först publicerad:	05/02/2013
Senaste uppdatering skickad:	04/29/2013
Senaste uppdatering publicerad:	05/02/2013
Faktiskt startdatum för studien:	10/31/2006
Uppskattat primärt slutdatum:	07/31/2011
Beräknat slutfört datum:	08/31/2011

Tillstånd eller sjukdom

Proliferative Thyroid Disease

Intervention / behandling

Dietary Supplement: A

Fas

Armgrupper

Ärm	Intervention / behandling
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

Urvalskriterier

Åldrar berättigade till studier	18 Years Till 18 Years
Kön som är berättigade till studier	All
Accepterar friska volontärer	Ja
Kriterier	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.

Resultat

Primära resultatåtgärder

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]

Sekundära resultatåtgärder

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

Nyckelord

neoplasms

diindolylmethane

kålsläktet

rödkål

anticancer