Trial Outcomes & Findings for Vitamin D and Screening Colonoscopy or Polyp Surveillance (NCT NCT02269332)

NCT ID: NCT02269332

Last Updated: 2024-01-22

Results Overview

Vitamin D blood levels will be obtained at the time of procedure.

• Recruitment status: COMPLETED
• Target enrollment: 298 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2024-01-22

Participant Flow

Participant milestones

Measure	Screening Colonoscopy Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks Screening Colonoscopy: we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance
Overall Study STARTED	298
Overall Study COMPLETED	228
Overall Study NOT COMPLETED	70

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D and Screening Colonoscopy or Polyp Surveillance

Baseline characteristics by cohort

Measure	Screening Colonoscopy n=298 Participants Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks Screening Colonoscopy: we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	298 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	134 Participants n=93 Participants
Sex: Female, Male Male	164 Participants n=93 Participants

PRIMARY outcome

Timeframe: 2 weeks

Vitamin D blood levels will be obtained at the time of procedure.

Outcome measures

Measure	Screening Colonoscopy n=228 Participants Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks Screening Colonoscopy: we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance
Serum Vitamin D vitamin D normal (>30ng/ml)	73 Participants
Serum Vitamin D vitamin D insufficiency (<30ng/ml)	155 Participants

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Measure	Screening Colonoscopy n=228 Participants Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks Screening Colonoscopy: we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance
Adenomatous Polyps found to have adenomatous polyps	104 Participants
Adenomatous Polyps did not have adenomatous polyps	124 Participants

Adverse Events

Screening Colonoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Research Associate/Research Manager

Mike O'Callaghan Military Medical Center

Phone: 7026533583

Email: amanda.j.crawford.ctr@health.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place