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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00870961
• Other study ID #: NU 08I3
• Secondary ID: P30CA060553NU-08
• Status: Terminated
• Phase: N/A
• First received: March 26, 2009
• Last updated: September 13, 2013
• Start date: February 2009
• Est. completion date: June 2012

Study information

• Verified date: September 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Precancerous Condition
• Precancerous Conditions

Intervention

Dietary Supplement:
• cholecalciferol
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of compliance as assessed at 6 months		Following 6 months of study treatment	No
Primary	Rate of accrual		After accrual goal is reached	No
Secondary	Changes in pre- and post-treatment vitamin D levels		At baseline and following completion of study treatment	No
Secondary	Correlation of vitamin D levels with vitamin D modifiers (e.g., levels of skin pigmentation, dietary vitamin D intake, and sun exposure)		After completion of study treatment & final colonic biopsy	No