Colon CancerVitDColonNCT02269332
Vitamin D and Screening Colonoscopy or Polyp Surveillance
An observational study of Colon Cancer, run by Mike O'Callaghan Military Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Screening Colonoscopy
- How many people
- 298 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Nov 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- DoD beneficiaries 18 years or older
- Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks
Who cannot join
- Previous diagnosis of colorectal cancer, adenomatous polyps, and/or cancer
- Military trainees
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Federal Hospital/Nellis Air Force Base
Las Vegas, Nevada, 89191
About this study
Official title: Association of 25-OH Vitamin D Status With Findings on Screening Colonoscopy.
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).
Read the 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
- Being tested
- Screening Colonoscopy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening ColonoscopyOther
we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance
| Study group | Role | What they receive |
|---|---|---|
| Screening Colonoscopy | Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks Receives: Other: Screening Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Vitamin D
Vitamin D blood levels will be obtained at the time of procedure.
Measured: 2 weeks
Adenomatous Polyps
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Carl Bryce, MD, Principal investigator, Mike O'Callaghan Federal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269332
- Sponsor's protocol ID
- FWH20140085H
- Acronym
- VitDColon
- Status last verified
- Jan 2024
- First submitted
- 14 Oct 2014
- Last updated
- 22 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of 25-OH Vitamin D Status With Findings on Screening Colonoscopy.
- ClinicalTrials.gov ID
- NCT02269332
- Acronym / sponsor ID
- VitDColon / FWH20140085H
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- Aug 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Posted 22 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening Colonoscopy | – | Other: Screening ColonoscopyReferred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- DoD beneficiaries 18 years or older
- Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks
Key exclusion criteria (3 listed)
- Previous diagnosis of colorectal cancer, adenomatous polyps, and/or cancer
- Military trainees
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening Colonoscopywe will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance | Other | Screening Colonoscopy |
Primary outcome
Serum Vitamin D
Time frame: 2 weeks
Vitamin D blood levels will be obtained at the time of procedure.
Adenomatous Polyps
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Bryce, MD principal investigator
Mike O'Callaghan Federal Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Mike O'Callaghan Military Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Vitamin D (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.