Effect of Folate on Colonic and Blood Cells
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention
Measurements of established folate-related endpoints in DNA from blood mononuclear cells and rectal cells:
Peter Holt, MD
Principal Investigator
Rockefeller University and Strang Cancer Institute
United States: Food and Drug Administration
RUH IRB #PHO-0514-0305
NCT00220012
June 2003
September 2005
Name | Location |
---|---|
Rockefeller University Hospital | New York, New York 10021-6399 |