Antioxidant Supplement and Reduction of Metachronous Adenomas of the Large Bowel: a Double Blind Randomized Trial

Colorectal Adenomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01437826
• Other study ID #: IST-1988
• Status: Terminated
• Phase: Phase 3
• First received: September 14, 2011
• Last updated: September 19, 2011
• Start date: March 1988
• Est. completion date: June 1996

Study information

• Verified date: September 2011
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: AIFA
• Study type: Interventional

Clinical Trial Summary

The trial was aimed at evaluating the efficacy of a multiagent antioxidant compound (vitamin A, C, E, selenium and zinc) in reducing the incidence of metachronous adenomas of the large bowel after endoscopic polypectomy. This is a randomized study: a 50% reduction in the incidence of metachronous adenomas was expected in patients allocated to the "active" compound (intervention) arm as compared to those assigned to a placebo.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 411
• Est. completion date: June 1996
• Est. primary completion date: June 1996
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• age 25-75 years

• at least one histologically confirmed adenoma endoscopically removed from the large bowel resulting in a polyp-free colon-rectum (clean colon).

Exclusion Criteria:

• polypectomy performed more than 6 months before enrolment in the trial

• history of Familial Adenomatous Polyposis

• inflammatory bowel disease

• adenoma with invasive carcinoma

• ten or more adenomas

• large sessile adenoma (3 cm or more

• colorectal resection

• invasive cancer at any site

• life-threatening and/or chronic heart, liver or kidney diseases

• current use of vitamin or calcium supplements

• mental disability

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenomas

Intervention

Drug:
• antioxidants
tablets composed of 200 mcg selenium [as l-selenomethionine], 30 mg zinc, 2 mg vitamin A [retinol], 180 mg vitamin C [ascorbic acid] and 30 mg vitamin E [D-a-tocopherol acetate]
• placebo
placebo had an identical appearance as intervention

Locations

Country	Name	City	State
Italy	IRCCS Azienda Ospedale Università San Martino - IST Istituto Nazionale per la Ricerca sul Cancro	Genova

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy	LILT (Italian league against cancer)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of metachronous adenomas or cancer detected during endoscopic follow up examinations		five years	No