Evaluation of the Efficacy of a Combination of Micronutrients (Vitamin A, C, E, Selenium and Zinc) in Reducing the Incidence of Colorectal Metachronous Adenomas. A Double Blind, Phase III, Randomized, Placebo-controlled Trial
Adenomatous polyps (or adenoma) are benign lesions of the large bowel that are frequent in
people aged 60 or more: about one in four of them has at least one adenoma. In time,
adenoma could progress to cancer. Even though only a small rate of adenomas will develop
into cancer almost 70-80% of colorectal cancer origin from an adenoma and colorectal cancer
is one of the most frequent malignant tumors in the western world. Several epidemiological
studies showed that subjects who had low intake and/or low blood levels of selenium were at
increased risk of developing colorectal cancer.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
occurrence of metachronous adenomas or cancer detected during endoscopic follow up examinations
five years
No
Luigina A Bonelli, MD
Principal Investigator
IRCCS Azienda Ospedale Università San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genova - Italy
Italy: AIFA
IST-1988
NCT01437826
March 1988
June 1996
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