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Vitamin D and Screening Colonoscopy or Polyp Surveillance (VitDColon)

M

Mike O'Callaghan Military Hospital

Status

Completed

Conditions

Colon Cancer

Treatments

Other: Screening Colonoscopy

Study type

Observational

Funder types

Other U.S. Federal agency

Identifiers

NCT02269332
FWH20140085H

Details and patient eligibility

About

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).

Full 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)

Enrollment

298 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion:

  • 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

Trial design

298 participants in 1 patient group

Screening Colonoscopy
Description:
Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks
Treatment:
Other: Screening Colonoscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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