DIM as a Treatment for Thyroid Disease

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Спонсори

The New York Eye & Ear Infirmary

КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT01846364

BioSeek: nct01846364

Ключови думи

Резюме

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.

Дати

Последна проверка:	03/31/2013
Първо изпратено:	04/29/2013
Очаквано записване подадено:	04/29/2013
Първо публикувано:	05/02/2013
Изпратена последна актуализация:	04/29/2013
Последна актуализация публикувана:	05/02/2013
Действителна начална дата на проучването:	10/31/2006
Приблизителна дата на първично завършване:	07/31/2011
Очаквана дата на завършване на проучването:	08/31/2011

Състояние или заболяване

Proliferative Thyroid Disease

Интервенция / лечение

Dietary Supplement: A

Фаза

Групи за ръце

Arm	Интервенция / лечение
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

Критерии за допустимост

Възрасти, отговарящи на условията за проучване	18 Years Да се 18 Years
Полове, допустими за проучване	All
Приема здрави доброволци	Да
Критерии	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.

Резултат

Първични изходни мерки

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]

Вторични изходни мерки

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

Ключови думи

рак

diindolylmethane

зеле

brassica oleracea

противоракови