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


Phase 0
50 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Precancerous Condition

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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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of compliance as assessed at 6 months

Outcome Time Frame:

Following 6 months of study treatment

Safety Issue:

No

Principal Investigator

Halla Nimeiri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

NU 08I3

NCT ID:

NCT00870961

Start Date:

February 2009

Completion Date:

December 2015

Related Keywords:

  • Colorectal Cancer
  • Precancerous Condition
  • colon cancer
  • rectal cancer
  • adenomatous polyp
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Precancerous Conditions

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611