DIM as a Treatment for Thyroid Disease

Nur registrierte Benutzer können Artikel übersetzen

Einloggen Anmelden

Der Link wird in der Zwischenablage gespeichert

StatusBeendet

Sponsoren

The New York Eye & Ear Infirmary

KLINISCHE STUDIE: NCT01846364

BioSeek: nct01846364

Schlüsselwörter

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.

Termine

Zuletzt überprüft:	03/31/2013
Zuerst eingereicht:	04/29/2013
Geschätzte Einschreibung eingereicht:	04/29/2013
Zuerst veröffentlicht:	05/02/2013
Letztes eingereichtes Update:	04/29/2013
Letztes Update veröffentlicht:	05/02/2013
Tatsächliches Startdatum der Studie:	10/31/2006
Geschätztes primäres Abschlussdatum:	07/31/2011
Voraussichtliches Abschlussdatum der Studie:	08/31/2011

Zustand oder Krankheit

Proliferative Thyroid Disease

Intervention / Behandlung

Dietary Supplement: A

Phase

Armgruppen

Arm	Intervention / Behandlung
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

Zulassungskriterien

Altersberechtigt für das Studium	18 Years Zu 18 Years
Studienberechtigte Geschlechter	All
Akzeptiert gesunde Freiwillige	Ja
Kriterien	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.

Ergebnis

Primäre Ergebnismaße

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]

Sekundäre Ergebnismaße

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

Schlüsselwörter

krebs

diindolylmethane

kohl

gemüsekohl

Antikrebs