NCT01437826

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 1988

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1988

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1996

Completed
15.3 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
Last Updated

September 21, 2011

Status Verified

September 1, 2011

Enrollment Period

8.3 years

First QC Date

September 14, 2011

Last Update Submit

September 19, 2011

Conditions

Colorectal Adenomas

Keywords

chemopreventioncolorectal cancermetachronous adenomarandomized trial

Outcome Measures

Primary Outcomes (1)

  • occurrence of metachronous adenomas or cancer detected during endoscopic follow up examinations

    five years

Study Arms (2)

antioxidants

EXPERIMENTAL

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: antioxidants

Sugar pill

PLACEBO COMPARATOR

placebo had an identical appearance as intervention

Drug: placebo

Interventions

antioxidantsDRUG

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 \[D-α-tocopherol acetate\]

Also known as: Bio-selenium, Pharma Nord (DK)
antioxidants
placeboDRUG

placebo had an identical appearance as intervention

Also known as: placebo was provided by Pharma Nord
Sugar pill

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedale Università San Martino - IST Istituto Nazionale per la Ricerca sul Cancro

Genova, 16132, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Antioxidants

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Biological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of Chemicals

Study Officials

  • Luigina A Bonelli, MD

    IRCCS Azienda Ospedale Università San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genova - Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, responsible of the unit of secondary prevention and screening

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 21, 2011

Study Start

March 1, 1988

Primary Completion

June 1, 1996

Study Completion

June 1, 1996

Last Updated

September 21, 2011

Record last verified: 2011-09

Locations

IT(1)