Vitamin D and Screening Colonoscopy or Polyp Surveillance

Colon Cancer Clinical Trial

— VitDColon  

Official title:

Association of 25-OH Vitamin D Status With Findings on Screening Colonoscopy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269332
• Other study ID #: FWH20140085H
• Status: Completed
• Start date: August 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2024
• Source: Mike O'Callaghan Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Other:
• Screening Colonoscopy
we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance

Locations

Country	Name	City	State
United States	Mike O'Callaghan Federal Hospital/Nellis Air Force Base	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Mike O'Callaghan Military Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Vitamin D	Vitamin D blood levels will be obtained at the time of procedure.	2 weeks
Primary	Adenomatous Polyps		2 weeks