Effect of Folate on Colon and Blood Cells
|Subjects Will Have a Pre-cancerous Colorectal Polyp Family Member Has History of Colorectal Adenoma of Adenocarcinoma||Procedure: Folate depletion and supplementation||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Official Title:||Effect of Folate on Colonic and Blood Cells|
- Measurements of established folate-related endpoints in DNA from blood mononuclear cells and rectal cells:
- Luracil incorporation in blood mononuclear cells
- Strand breaks in the coding region of p53 in blood cells and rectal biopsy cells
- DNA methylation (overall, p53, coding, p16 promotor. MLH1 promotor) in blood cells and rectal biopsy cells
- Measurements of differential gene expression in colonic and blood cells by microarray analysis, further defining folate's action in modifying cell cycle activity, cell maturation, signal transduction and oncogene expression.
|Study Start Date:||June 2003|
|Study Completion Date:||September 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220012
|United States, New York|
|Rockefeller University Hospital|
|New York, New York, United States, 10021|
|Principal Investigator:||Peter Holt, MD||Rockefeller University and Strang Cancer Institute|