Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-09 @ 4:08 AM
Study NCT ID:
NCT02269332
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2014-10-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin D and Screening Colonoscopy or Polyp Surveillance
Sponsor:
Mike O'Callaghan Military Hospital
Organization:
Study Overview
Official Title:
Association of 25-OH Vitamin D Status With Findings on Screening Colonoscopy.
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VitDColon
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: