Trial · NCT00078897
Selenium for Prevention of Adenomatous Colorectal Polyps
NCT00078897, Phase 3, Terminated, University of Arizona; results first posted 2019-09-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Selenium for Prevention of Adenomatous Colorectal Polyps. Trials, record NCT00078897. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00078897
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selenium for Prevention of Adenomatous Colorectal Polyps
- NCT number
- NCT00078897
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,621 participants, actual
- Lead sponsor
- University of Arizona
- Conditions
- Colorectal Cancer, Adenomatous Colorectal Polyps, Precancerous Condition
- Interventions
- Selenium
- First posted
- 2004-03-09
- Last updated
- 2019-09-24
- Results first posted
- 2019-09-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Recurrent Adenomas at Surveillance Colonoscopy | 3 to 5 years after baseline colonoscopy | Detection of metachronous colorectal adenomas during follow-up, by treatment, in the original cohort. Surveillance colonoscopy is recommended 3 to 5 years after removal of colorectal adenoma(s). Participants will remain on the study intervention until their surveillance colonoscopy. Surveillance colonoscopy is determined by participants' GI physician. |
| Primary | Median Selenium Blood Levels at One Year. | One year | Adequate adherence to long-term selenium treatment as measured by blood selenium levels (ng/mL) at one year. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Recurrent Adenomas at Surveillance Colonoscopy | 3 to 5 years after baseline colonoscopy | Adenomas | NUMBER | |
| PRIMARY | Median Selenium Blood Levels at One Year. | One year | ng/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Recurrent Adenomas at Surveillance Colonoscopy | Selenium | 302 | Adenomas | ||
| Number of Recurrent Adenomas at Surveillance Colonoscopy | Placebo | 295 | Adenomas | ||
| Median Selenium Blood Levels at One Year. | Selenium | 205.4 | Inter-Quartile Range 100.7 to 367.6 | ng/mL | |
| Median Selenium Blood Levels at One Year. | Placebo | 140.0 | Inter-Quartile Range 84.9 to 270.2 | ng/mL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selenium | 809 | |
| Overall Study | STARTED | Placebo | 812 | |
| Overall Study | COMPLETED | Selenium | 685 | |
| Overall Study | COMPLETED | Placebo | 689 | |
| Overall Study | NOT COMPLETED | Selenium | 124 | |
| Overall Study | NOT COMPLETED | Placebo | 123 |
Source ClinicalTrials.gov
Adverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Abdominal aortic aneurysm | Vascular disorders | Selenium | 0 | 685 | |
| serious | Abdominal aortic aneurysm | Vascular disorders | Placebo | 2 | 689 | |
| serious | Abdominal Pain | Gastrointestinal disorders | Selenium | 1 | 685 | |
| serious | Abdominal Pain | Gastrointestinal disorders | Placebo | 4 | 689 | |
| serious | Acute appendicitis | Gastrointestinal disorders | Selenium | 1 | 685 | |
| serious | Acute appendicitis | Gastrointestinal disorders | Placebo | 3 | 689 | |
| serious | Acute cholecystitis | Hepatobiliary disorders | Selenium | 0 | 685 | |
| serious | Acute cholecystitis | Hepatobiliary disorders | Placebo | 3 | 689 | |
| serious | Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Selenium | 48 | 685 | |
| serious | Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 67 | 689 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selenium | 11 | 685 |
| Total, all-cause mortality | Placebo | 10 | 689 |
| Total, other adverse events | Selenium | 0 | 685 |
| Total, other adverse events | Placebo | 0 | 689 |
| Total, serious adverse events | Selenium | 228 | 685 |
| Total, serious adverse events | Placebo | 226 | 689 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA023074 | University of Arizona Cancer Center - Cancer Center Support Grant | THEODORESCU, DAN | UNIVERSITY OF ARIZONA | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| P01CA041108 | Colon Cancer Prevention Program Project Grant | LANCE, M. PETER | UNIVERSITY OF ARIZONA | NATIONAL CANCER INSTITUTE | 1986 to 2009 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Selenium vs Placebo: deaths from any cause | Trial comparisons |
| Selenium vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00078897
GET https://conductscience.org/api/trials/v1/NCT00078897/events?page=2