Colorectal CancerNCT00870961
Vitamin D Supplement in Preventing Colon Cancer in African Americans With Colon Polyps
A study testing cholecalciferol in people with Colorectal Cancer and Precancerous Condition, run by Northwestern University at 2 sites in United States.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of vitamin D may keep colorectal cancer from forming in patients with colon polyps. PURPOSE: This randomized phase I trial is studying a vitamin D supplement to see how well it works compared with a placebo in preventing… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colorectal Cancer, Precancerous Condition
- What is being tested?
- cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenomatous polyp
- At least 1 adenoma
- Self-identified as an African American AND undergoing screening or diagnostic colonoscopy at the University of Chicago
- No history of colon or rectal cancer or hereditary or familial colon cancer (e.g., hereditary non-polyposis colon cancer or familial adenomatous polyposis)
PATIENT CHARACTERISTICS:
- Total bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal
- Albumin ≥ 3.0 mg/dL
- Baseline serum calcium level normal
- Not pregnant
- No history of thyroid disease
- No history of renal stones
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other concurrent vitamin D intake
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
About this study
Official title: Vitamin D Intervention For Colon Cancer Prevention In African-Americans-A Pilot Study
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of vitamin D may keep colorectal cancer from forming in patients with colon polyps.
PURPOSE: This randomized phase I trial is studying a vitamin D supplement to see how well it works compared with a placebo in preventing colorectal cancer in African Americans with colon polyps.
Read the detailed description
OBJECTIVES:
Primary
- To determine the accrual rate of African Americans with adenomatous polyps to a 6-month randomized intervention trial comprising supplementation with either cholecalciferol (vitamin D3) or placebo.
- To determine the compliance rates in patients treated with these regimens.
Secondary
- To compare changes in pre- and post-treatment vitamin D levels in patients treated with these regimens.
- To correlate vitamin D levels with vitamin D modifiers, such as levels of skin pigmentation, dietary vitamin D intake, and sun exposure in this patient population.
OUTLINE: Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral cholecalciferol (vitamin D3) supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral placebo supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
Patients complete questionnaires about demographics, dietary vitamin D intake, personal history (e.g., ancestry, alcohol and tobacco intake, occupation, height, and weight), medical history (e.g., personal and family history of colorectal cancer and polyps), and ultraviolet radiation exposure.
Blood samples are collected at baseline and at 6 months for correlative laboratory studies. Blood samples are analyzed for vitamin D levels by enzyme immunoassay. Patients also undergo assessment of skin pigmentation in sunprotected and sunexposed areas of skin by reflectance spectrometry at baseline.
- Conditions
- Colorectal Cancer, Precancerous Condition
- Being tested
- cholecalciferol, placebo
- Keywords
- colon cancer, rectal cancer, adenomatous polyp
- Medical subject headings
- Colorectal Neoplasms, Precancerous Conditions, Colonic Neoplasms, Rectal Neoplasms, Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDietary supplement
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral cholecalciferol (vitamin D3) supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity. Receives: Dietary Supplement: cholecalciferol |
| Arm II | Placebo comparator | Patients receive oral placebo supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of compliance as assessed at 6 months
Measured: Following 6 months of study treatment
Rate of accrual
Measured: After accrual goal is reached
Secondary outcomes (2)
Changes in pre- and post-treatment vitamin D levels
Measured: At baseline and following completion of study treatment
Correlation of vitamin D levels with vitamin D modifiers (e.g., levels of skin pigmentation, dietary vitamin D intake, and sun exposure)
Measured: After completion of study treatment & final colonic biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: PI changed institutions and accrual was not completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Halla Nimeiri, MD, Principal investigator, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870961
- Sponsor's protocol ID
- NU 08I3
- Other IDs
- P30CA060553, NU-08I3, STU00005964
- Status last verified
- Sep 2013
- First submitted
- 26 Mar 2009
- Last updated
- 16 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Intervention For Colon Cancer Prevention In African-Americans-A Pilot Study
- ClinicalTrials.gov ID
- NCT00870961
- Acronym / sponsor ID
- NU 08I3
- Conditions
- Colorectal Cancer, Precancerous Condition
- Keywords
- colon cancer, rectal cancer, adenomatous polyp
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI changed institutions and accrual was not completed.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of vitamin D may keep colorectal cancer from forming in patients with colon polyps.
PURPOSE: This randomized phase I trial is studying a vitamin D supplement to see how well it works compared with a placebo in preventing colorectal cancer in African Americans with colon polyps.
Detailed description
OBJECTIVES:
Primary
- To determine the accrual rate of African Americans with adenomatous polyps to a 6-month randomized intervention trial comprising supplementation with either cholecalciferol (vitamin D3) or placebo.
- To determine the compliance rates in patients treated with these regimens.
Secondary
- To compare changes in pre- and post-treatment vitamin D levels in patients treated with these regimens.
- To correlate vitamin D levels with vitamin D modifiers, such as levels of skin pigmentation, dietary vitamin D intake, and sun exposure in this patient population.
OUTLINE: Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral cholecalciferol (vitamin D3) supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral placebo supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
Patients complete questionnaires about demographics, dietary vitamin D intake, personal history (e.g., ancestry, alcohol and tobacco intake, occupation, height, and weight), medical history (e.g., personal and family history of colorectal cancer and polyps), and ultraviolet radiation exposure.
Blood samples are collected at baseline and at 6 months for correlative laboratory studies. Blood samples are analyzed for vitamin D levels by enzyme immunoassay. Patients also undergo assessment of skin pigmentation in sunprotected and sunexposed areas of skin by reflectance spectrometry at baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Dietary Supplement: cholecalciferolPatients receive oral cholecalciferol (vitamin D3) supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity. |
| Arm II | Placebo comparator | Other: placeboPatients receive oral placebo supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cholecalciferolGiven orally | Dietary supplement | Arm I |
| placeboGiven orally | Other | Arm II |
Primary outcome
Rate of compliance as assessed at 6 months
Time frame: Following 6 months of study treatment
Rate of accrual
Time frame: After accrual goal is reached
2 secondary outcomes
Changes in pre- and post-treatment vitamin D levels
Time frame: At baseline and following completion of study treatment
Correlation of vitamin D levels with vitamin D modifiers (e.g., levels of skin pigmentation, dietary vitamin D intake, and sun exposure)
Time frame: After completion of study treatment & final colonic biopsy
Results and safety
The study was stopped early (reason given: PI changed institutions and accrual was not completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
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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.
Halla Nimeiri, MD principal investigator
Robert H. Lurie Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol in people with Colorectal Cancer and Precancerous Condition, run by Northwestern University at 2 sites 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?
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: stopped early, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: PI changed institutions and accrual was not completed.). Results are not available in the source record.
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?
Rate of compliance as assessed at 6 months (time frame: Following 6 months of study treatment). 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 16 Sep 2013.