Vitamin D and Screening Colonoscopy or Polyp Surveillance

Completed

• Conditions: Colon Cancer
• Interventions: Other: Screening Colonoscopy

• Registration Number: NCT02269332
• Lead Sponsor: Mike O'Callaghan Military Hospital

Brief Summary

The investigators will recruit DoD beneficiaries 18 years or older, that have been referred for a screening colonoscopy or polyp surveillance (or had one in the last 2 weeks), and have no previous diagnosis of colorectal cancer. They will have a 25 OH Vitamin D level drawn to determine if there is an association between the level obtained and findings on colonoscopy, or previous findings (if repeating).

Detailed Description

DoD beneficiaries age 18 or older will be recruited from the clinics at the Mike O'Callaghan Federal Medical Center (MOFMC). Subjects meeting the inclusion/exclusion criteria will be offered an opportunity to participate:

Screening Visit:

* Obtain signed Informed Consent Document and HIPAA Authorization (research-driven).

* Record: Date of birth, age, gender, race, ethnicity, current email address, height (in inches), weight (in pounds), waist circumference (in inches) measurement, blood pressure, and whether subject is taking or has taken any vitamin D supplement or derivative, and if so, note the dosage, frequency, and duration of therapy.

* Subjects will be told to fast for at least 10 hours prior to Visit 1

Visit 1 (within two weeks of their screening colonoscopy):

-Subjects will have the following research-driven blood test drawn which include: Serum 25-OH vitamin D via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn)

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-21
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2020-06-22
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-19
• Last Update Submitted: 2024-01-19
• Results First Posted: 2024-01-22
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screening Colonoscopy	Screening Colonoscopy	Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks

Primary Outcome Measures

Name	Time	Method
Adenomatous Polyps	2 weeks
Serum Vitamin D	2 weeks	Vitamin D blood levels will be obtained at the time of procedure.

Trial Locations

Locations (1)

Mike O'Callaghan Federal Hospital/Nellis Air Force Base; 🇺🇸 Las Vegas, Nevada, United States