Trial Information

Vitamin D Intervention For Colon Cancer Prevention In African-Americans-A Pilot Study

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.