Vitamin D and Screening Colonoscopy or Polyp Surveillance

NCT ID: NCT02269332

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 298 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-11-30

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)

Conditions

Colon Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Screening Colonoscopy

Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks

Screening Colonoscopy

Intervention Type: OTHER

we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance

Interventions

Screening Colonoscopy

we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• DoD beneficiaries 18 years or older
• Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks

Exclusion:

• Previous diagnosis of colorectal cancer, adenomatous polyps, and/or cancer
• Military trainees
• Pregnant women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mike O'Callaghan Military Hospital

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl Bryce, MD

Role: PRINCIPAL_INVESTIGATOR

Mike O'Callaghan Federal Medical Center

Locations

Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

FWH20140085H

Identifier Type: -

Identifier Source: org_study_id