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

NCT00870961 | Terminated

• 4 other identifiers: NU 08I3P30CA060553NU-08I3STU00005964
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Colorectal Cancer; Precancerous Condition

Keywords

colon cancer; rectal cancer; adenomatous polyp

Outcome Measures

Primary Outcomes (2)

• Rate of compliance as assessed at 6 months

  Following 6 months of study treatment

• Rate of accrual

  After accrual goal is reached

Secondary Outcomes (2)

• Changes in pre- and post-treatment vitamin D levels

  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)

  After completion of study treatment & final colonic biopsy

Study Arms (2)

Arm I

EXPERIMENTAL

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

Arm II

PLACEBO COMPARATOR

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

Other: placebo

Interventions

cholecalciferol DIETARY_SUPPLEMENT

Given orally

Arm I

placebo OTHER

Given orally

Arm II

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Precancerous Conditions; Colonic Neoplasms; Rectal Neoplasms; Adenomatous Polyps

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Halla Nimeiri, MD

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 27, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 16, 2013

Record last verified: 2013-09

Locations

US (2)