NCT00220012

Effect of Folate on Colon and Blood Cells

Effect of Folate on Colonic and Blood Cells

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 40 Years – 72 Years
• Healthy volunteers: Accepted

Summary

This study looks at the effect of folate supplementation and depletion on the blood cells and the colorectal cells. To examine the effect of these changes, blood samples and colorectal biopsy samples are collected. The genetic material (RNA and DNA) is examined to see what changes occur during the depletion and supplementation of folate. The hypothesis is that folate may help prevent colon cancer

Detailed description

Folate Depletion Arm and Supplementation Arm: The folate depletion study requires an 8-week run-in period. During this run-in period, all participants will eat an average folate diet with no high folate containing foods. There are two screening visits during this period where initial blood-work is done and participants undergo nutritional consultation. Following the 8-week run-in period, subjects in the folate depletion arm will be hospitalized for approximately 3 months at the Rockefeller University Hospital. You may leave the hospital during the day, but are required to return each evening. During this entire time, subjects are given a low folate diet. During the last month of the study, folate supplements are given to replace folate in the body. A follow-up visit is required approximately 1 month after the study period. Blood will be drawn every two weeks. Four sigmoidoscopies will be taken at approximately monthly intervals. A male is required to use an effective form of birth control throughout his participation in the study and for two months after the study ends. The folate supplementation study requires an 8-week run-in period. During this run-in period, all participants will eat an average folate diet with no high folate containing foods. There are two screening visits during this period where initial blood-work is done and participants undergo nutritional consultation. Following the 8-week run-in period, subjects in the folate supplementation arm will be given a folate supplement for 8 weeks. During this entire time, subjects will continue to eat an average folate diet with no high folate containing foods. Blood samples and colorectal mucosa samples obtained during a sigmoidoscopy will be taken 3 times at 4 week intervals.

Conditions

• Subjects Will Have a Pre-cancerous Colorectal Polyp
• Family Member Has History of Colorectal Adenoma of Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Folate depletion and supplementation

Timeline

• Start date: 2003-06-01
• Completion: 2008-09-01
• First posted: 2005-09-22
• Last updated: 2013-11-15

Locations

1 site across 1 country: United States