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

NCT01437826 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2011-09-21

No results posted yet for this study

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.

Conditions

  • Colorectal Adenomas

Interventions

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 \[D-α-tocopherol acetate\]

DRUG

placebo

placebo had an identical appearance as intervention

Sponsors & Collaborators

  • LILT (Italian league against cancer)

    collaborator UNKNOWN

  • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

    lead OTHER

Principal Investigators

  • Luigina A Bonelli, MD · IRCCS Azienda Ospedale Università San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genova - Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1988-03-31
Primary Completion
1996-06-30
Completion
1996-06-30

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01437826 on ClinicalTrials.gov