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Folate-Depleted Diet Compared With Folate-Supplemented Diet in Preventing Colorectal Cancer in Patients at High Risk for Colorectal Cancer

NCT00096330 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-01-13

No results posted yet for this study

Summary

RATIONALE: Chemoprevention therapy is the use of certain agents to try to prevent the development of cancer. The use of folic acid may be effective in preventing colorectal cancer. Eating a diet rich in folic acid may prevent the development of colorectal cancer.

PURPOSE: This randomized phase I trial is studying how well a folate-depleted diet works compared to a folate-supplemented diet in preventing colorectal cancer in patients who are at high risk for developing colorectal cancer.

Conditions

Interventions

DIETARY_SUPPLEMENT

dietary intervention

oral folic acid supplementation once daily on days 57-84

DIETARY_SUPPLEMENT

folic acid

oral folic acid supplementation once daily on days 1-56.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • James Marshall, PhD · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2007-02-28
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00096330 on ClinicalTrials.gov