Vitamin D Supplement in Preventing Colon Cancer in African Americans With Colon Polyps

Colorectal Cancer Clinical Trial

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

Status Terminated

Clinical 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 colorectal cancer in African Americans with colon polyps.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Precancerous Condition
• Precancerous Conditions

• NCT number: NCT00870961
• Study type: Interventional
• Source: Northwestern University
• Status: Terminated
• Phase: N/A
• Start date: February 2009
• Completion date: June 2012