Trial Outcomes & Findings for Selenium for Prevention of Adenomatous Colorectal Polyps (NCT NCT00078897)
NCT ID: NCT00078897
Last Updated: 2019-09-24
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1621 participants
Primary outcome timeframe
3 to 5 years after baseline colonoscopy
Results posted on
2019-09-24
Participant Flow
Participants were recruited through clinical centers in Arizona, Colorado, Texas, and New York following ambulatory colonoscopies. Eligible participants were between age 40 and 80 years and had undergone colonoscopic removal of one or more colorectal adenomas 3 mm or larger within six months prior to random assignment.
Participant milestones
| Measure |
Selenium
Participants receive oral selenium 200 mcg once daily.
Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled.
|
Placebo
Participants receive oral placebo once daily.
Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled.
|
|---|---|---|
|
Overall Study
STARTED
|
809
|
812
|
|
Overall Study
COMPLETED
|
685
|
689
|
|
Overall Study
NOT COMPLETED
|
124
|
123
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Selenium for Prevention of Adenomatous Colorectal Polyps
Baseline characteristics by cohort
| Measure |
Selenium
n=685 Participants
Participants receive oral selenium 200 mcg once daily.
Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled.
|
Placebo
n=689 Participants
Participants receive oral placebo once daily.
Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled.
|
Total
n=1374 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
242 Participants
n=5 Participants
|
234 Participants
n=7 Participants
|
476 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
443 Participants
n=5 Participants
|
455 Participants
n=7 Participants
|
898 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
660 Participants
n=5 Participants
|
650 Participants
n=7 Participants
|
1310 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
652 Participants
n=5 Participants
|
650 Participants
n=7 Participants
|
1302 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
685 participants
n=5 Participants
|
689 participants
n=7 Participants
|
1374 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 to 5 years after baseline colonoscopyDetection 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.
Outcome measures
| Measure |
Selenium
n=685 Participants
Participants receive oral selenium 200 mcg once daily.
Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled.
|
Placebo
n=689 Participants
Participants receive oral placebo once daily.
Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled.
|
|---|---|---|
|
Number of Recurrent Adenomas at Surveillance Colonoscopy
|
302 Adenomas
|
295 Adenomas
|
PRIMARY outcome
Timeframe: One yearAdequate adherence to long-term selenium treatment as measured by blood selenium levels (ng/mL) at one year.
Outcome measures
| Measure |
Selenium
n=685 Participants
Participants receive oral selenium 200 mcg once daily.
Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled.
|
Placebo
n=689 Participants
Participants receive oral placebo once daily.
Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled.
|
|---|---|---|
|
Median Selenium Blood Levels at One Year.
|
205.4 ng/mL
Interval 100.7 to 367.6
|
140.0 ng/mL
Interval 84.9 to 270.2
|
Adverse Events
Selenium
Serious events: 228 serious events
Other events: 0 other events
Deaths: 11 deaths
Placebo
Serious events: 226 serious events
Other events: 0 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Selenium
n=685 participants at risk
Participants receive oral selenium 200 mcg once daily.
Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled.
|
Placebo
n=689 participants at risk
Participants receive oral placebo once daily.
Selenium: Participants will be randomized either to selenium or placebo, taking the randomized intervention for 3 to 5 years, depending on when their recommended follow up colonoscopy is scheduled.
|
|---|---|---|
|
Vascular disorders
Abdominal aortic aneurysm
|
0.00%
0/685
|
0.29%
2/689
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.15%
1/685
|
0.58%
4/689
|
|
Gastrointestinal disorders
Acute appendicitis
|
0.15%
1/685
|
0.44%
3/689
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.00%
0/685
|
0.44%
3/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
7.0%
48/685
|
9.7%
67/689
|
|
Cardiac disorders
Myocardial Infarction
|
0.88%
6/685
|
0.87%
6/689
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.44%
3/685
|
1.3%
9/689
|
|
Immune system disorders
Allergic reaction
|
0.29%
2/685
|
0.29%
2/689
|
|
Immune system disorders
Angioedema
|
0.00%
0/685
|
0.29%
2/689
|
|
Cardiac disorders
Angina
|
1.8%
12/685
|
1.7%
12/689
|
|
Cardiac disorders
Chest pain
|
1.5%
10/685
|
1.6%
11/689
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.73%
5/685
|
0.15%
1/689
|
|
Gastrointestinal disorders
Diverticulitis
|
0.29%
2/685
|
0.29%
2/689
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.44%
3/685
|
0.00%
0/689
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.88%
6/685
|
0.58%
4/689
|
|
Musculoskeletal and connective tissue disorders
Arthritis/Degenerative joint disease
|
2.6%
18/685
|
2.3%
16/689
|
|
Nervous system disorders
Stroke/Transient ischemic attack
|
1.5%
10/685
|
1.5%
10/689
|
|
Cardiac disorders
Atrial fibrillation/arrhythmia
|
1.9%
13/685
|
1.3%
9/689
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.6%
11/685
|
0.87%
6/689
|
|
Infections and infestations
Cellulitis
|
0.73%
5/685
|
0.44%
3/689
|
|
Gastrointestinal disorders
GI Bleed
|
0.58%
4/685
|
1.0%
7/689
|
|
Cardiac disorders
Myocardial infarction
|
0.44%
3/685
|
0.87%
6/689
|
|
Gastrointestinal disorders
Bowel obstruction
|
1.2%
8/685
|
0.15%
1/689
|
|
Infections and infestations
Infection
|
0.88%
6/685
|
1.3%
9/689
|
|
Nervous system disorders
Syncope/dizziness
|
0.58%
4/685
|
0.73%
5/689
|
|
Cardiac disorders
Misc. cardiac disorders
|
2.5%
17/685
|
3.8%
26/689
|
|
Gastrointestinal disorders
Misc. GI disorders
|
1.2%
8/685
|
1.9%
13/689
|
|
Ear and labyrinth disorders
Misc. ear and labyrinth disorders
|
0.44%
3/685
|
0.15%
1/689
|
|
Nervous system disorders
Misc. nervous system disorders
|
1.2%
8/685
|
0.29%
2/689
|
|
Psychiatric disorders
Misc. psychiatric disorders
|
0.44%
3/685
|
0.29%
2/689
|
|
Reproductive system and breast disorders
Misc. reproductive and breast disorders
|
0.88%
6/685
|
0.73%
5/689
|
|
Vascular disorders
Misc. vascular disorders
|
1.2%
8/685
|
1.6%
11/689
|
|
Renal and urinary disorders
Misc. renal and urinary disorders
|
1.3%
9/685
|
2.0%
14/689
|
|
Hepatobiliary disorders
Misc. hepatobiliary disorders
|
0.73%
5/685
|
0.58%
4/689
|
|
Metabolism and nutrition disorders
Misc. metabolism and nutrition disorders
|
0.44%
3/685
|
0.29%
2/689
|
|
Respiratory, thoracic and mediastinal disorders
Misc. respiratory disorders
|
0.73%
5/685
|
1.0%
7/689
|
|
Musculoskeletal and connective tissue disorders
Misc. musculoskeletal disorders
|
1.2%
8/685
|
0.58%
4/689
|
|
General disorders
Miscellaneous
|
0.15%
1/685
|
0.15%
1/689
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Misc. neoplasms
|
0.58%
4/685
|
0.87%
6/689
|
|
Injury, poisoning and procedural complications
Injury
|
0.73%
5/685
|
0.58%
4/689
|
|
Endocrine disorders
Misc. endocrine disorders
|
0.29%
2/685
|
0.15%
1/689
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place