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

Northwestern University

Status: Terminated

Conditions: Precancerous Condition; Colorectal Cancer

Treatments: Dietary Supplement: cholecalciferol; Other: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00870961

STU00005964 (Other Identifier)

NU-08I3

P30CA060553 (U.S. NIH Grant/Contract)

NU 08I3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

Arm I

Experimental group

Description:

Patients receive oral cholecalciferol (vitamin D3) supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.

Treatment:

Dietary Supplement: cholecalciferol

Arm II

Placebo Comparator group

Description:

Patients receive oral placebo supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.

Treatment:

Other: placebo