Family Member Has History of Colorectal Adenoma of Adenocarcinoma Clinical Trial
Official title:
Effect of Folate on Colonic and Blood Cells
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
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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention