Clinical Trial: Vitamin D Supplement in Preventing Colon Cancer in African Americans With Colon Polyps

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:

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 a
Sponsor: Northwestern University

Current 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 ]


Original Primary Outcome:

  • Rate of compliance as assessed at 6 months
  • Rate of accrual


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Changes in pre- and post-treatment vitamin D levels
  • Correlation of vitamin D levels with vitamin D modifiers (e.g., levels of skin pigmentation, dietary vitamin D intake, and sun exposure)


Information By: Northwestern University

Dates:
Date Received: March 26, 2009
Date Started: February 2009
Date Completion:
Last Updated: September 13, 2013
Last Verified: September 2013