Vitamin D Supplement in Preventing Colon Cancer in African Americans With Colon Polyps
NCT ID: NCT00870961
Last Updated: 2013-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
22 participants
INTERVENTIONAL
2009-02-28
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I
Patients receive oral cholecalciferol (vitamin D3) supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
cholecalciferol
Given orally
Arm II
Patients receive oral placebo supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
placebo
Given orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cholecalciferol
Given orally
placebo
Given orally
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Halla Nimeiri, MD
Role: PRINCIPAL_INVESTIGATOR
Robert H. Lurie Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NU-08I3
Identifier Type: -
Identifier Source: secondary_id
STU00005964
Identifier Type: OTHER
Identifier Source: secondary_id
NU 08I3
Identifier Type: -
Identifier Source: org_study_id