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

September 13, 2013 updated by: Northwestern University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive oral cholecalciferol (vitamin D3) supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
Dietary supplement: cholecalciferol
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
Other: placebo
Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of compliance as assessed at 6 months
Time Frame: Following 6 months of study treatment
Following 6 months of study treatment
Rate of accrual
Time Frame: After accrual goal is reached
After accrual goal is reached

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in pre- and post-treatment vitamin D levels
Time Frame: At baseline and following completion of study treatment
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
After completion of study treatment & final colonic biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Halla Nimeiri, MD, Robert H. Lurie Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimate)

March 27, 2009

Study Record Updates

Last Update Posted (Estimate)

September 16, 2013

Last Update Submitted That Met QC Criteria

September 13, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU 08I3
  • P30CA060553 (U.S. NIH Grant/Contract)
  • NU-08I3
  • STU00005964 (Other Identifier: Northwestern University IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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