Clinical trial NCT00870961: Vitamin D Supplement in Preventing Colon Cancer in African Americans With Colon Polyps
Official title: Vitamin D Intervention For Colon Cancer Prevention In African-Americans-A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Precancerous Condition
Keywords: colon cancer
rectal cancer
adenomatous polyp
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-03-27
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of compliance as assessed at 6 months
timeFrame: Following 6 months of study treatment
measure: Rate of accrual
timeFrame: After accrual goal is reached
Secondary outcomes:
measure: Changes in pre- and post-treatment vitamin D levels
timeFrame: At baseline and following completion of study treatment
measure: Correlation of vitamin D levels with vitamin D modifiers (e.g., levels of skin pigmentation, dietary vitamin D intake, and sun exposure)
timeFrame: After completion of study treatment & final colonic biopsy
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Halla Nimeiri, MD
role: PRINCIPAL_INVESTIGATOR
References: