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

This study has been terminated.
(PI changed institutions and accrual was not completed.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00870961
First received: March 26, 2009
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Colorectal Cancer
Precancerous Condition
Dietary Supplement: cholecalciferol
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Vitamin D Intervention For Colon Cancer Prevention In African-Americans-A Pilot Study

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Rate of compliance as assessed at 6 months [ Time Frame: Following 6 months of study treatment ] [ Designated as safety issue: No ]
  • Rate of accrual [ Time Frame: After accrual goal is reached ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in pre- and post-treatment vitamin D levels [ Time Frame: At baseline and following completion of study treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: February 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870961

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Halla Nimeiri, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00870961     History of Changes
Other Study ID Numbers: NU 08I3, P30CA060553, NU-08I3, STU00005964
Study First Received: March 26, 2009
Last Updated: September 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
colon cancer
rectal cancer
adenomatous polyp

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Precancerous Conditions
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 22, 2014