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

Northwestern University22 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Colorectal Cancer Precancerous Condition

Interventions

cholecalciferolDIETARY_SUPPLEMENT

Given orally

placeboOTHER

Given orally

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (2)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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