Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220012
Status:
COMPLETED
Last Update Posted:
2013-11-15
First Post:
2005-09-15
Brief Title:
Effect of Folate on Colon and Blood Cells
Sponsor:
Rockefeller University
Organization:
Rockefeller University
Study Overview
Official Title:
Effect of Folate on Colonic and Blood Cells
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01-CN-35111 | None | None | None |