Ignite Creation Date:
2024-05-05 @ 11:50 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01426490
Status:
UNKNOWN
Last Update Posted:
2014-02-19
First Post:
2011-08-29
Brief Title:
The Effects of Vitamin B-6 Status on Homocysteine Oxidative Stress One-carbon Metabolism and Methylation Cross-section Case-control Intervention and Follow-up Studies in Colorectal Cancer
Sponsor:
Taichung Veterans General Hospital
Organization:
Taichung Veterans General Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2011-08
Last Known Status:
RECRUITING
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:
Vitamin B-6 folate and homocysteine may play a critical role in the colorectal cancer progression This is a 4-y study and the specific aims are 1 to compare vitamin B-6 folate and homocysteine status oxidative stress antioxidant activities and DNA methylation between subjects with colorectal polyps and colorectal cancer 2 to study the effects of vitamin B-6 folate and homocysteine status on oxidative stress antioxidant activities and DNA methylation in colorectal cancer patients 3 to evaluate whether folic acid andor pyridoxine supplementation had a beneficial effect on oxidative stress antioxidant activities and DNA methylation in patients with colorectal 4 to compare vitamin B-6 folate and homocysteine status oxidative stress antioxidant activities and DNA methylation between colorectal cancer patients and age- sex-matched healthy subjects 5 to evaluate the effect of vitamin B-6 folate and homocysteine status oxidative stress antioxidant activities and DNA methylation on the risk of colorectal cancer odds ratio 6 to follow the effects of vitamin B-6 folate and homocysteine status oxidative stress antioxidant activities and DNA methylation on the occurrence of colorectal cancer 7 to follow the effects of pyridoxine andor folic acid supplementation on the occurrence of colorectal cancer
This protocol is designed as a hospital-based cross-sectional case-control double blinded randomized placebo-controlled intervention and follow-up trial Three hundred colorectal cancer patients and 300 age- sex-matched controls who meet the inclusion criteria will be recruited from Taichung General Veterans Hospital If cancer patients plasma pyridoxal 5-phosphate PLP level less than 30 nmolL will be asked to participate the intervention study and will be blinded and randomly assigned to either the 1 control vitamin C 100 mgd 2 50 mg vitamin B-6 3 400 microgramd folic acid or 4 vitamin B-6 50 mgd plus folic acid 400 microgramd for 1 year Data on demography anthropometry medical history food frequency questionnaire and 24-h diet recall will be collected Cancer patients will have fasting blood drawn before surgery or receiving chemotherapy Additionally fasting blood samples will be obtained at month 0 3 6 9 and 12 during intervention period and at month 6 12 18 24 30 36 42 and 48 during follow-up Hematological plasma and erythrocyte PLP plasma pyridoxal and 4-pyridoxic acid serum and erythrocyte folate serum vitamin B-12 homocysteine SAM SAH lipid peroxidation indicators TBARS oxidized LDL glutathione antioxidant enzymatic activities and DNA methylation and MTHFR 677CT polymorphism will be measured
This protocol is designed as a hospital-based cross-sectional case-control double blinded randomized placebo-controlled intervention and follow-up trial Three hundred colorectal cancer patients and 300 age- sex-matched controls who meet the inclusion criteria will be recruited from Taichung General Veterans Hospital If cancer patients plasma pyridoxal 5-phosphate PLP level less than 30 nmolL will be asked to participate the intervention study and will be blinded and randomly assigned to either the 1 control vitamin C 100 mgd 2 50 mg vitamin B-6 3 400 microgramd folic acid or 4 vitamin B-6 50 mgd plus folic acid 400 microgramd for 1 year Data on demography anthropometry medical history food frequency questionnaire and 24-h diet recall will be collected Cancer patients will have fasting blood drawn before surgery or receiving chemotherapy Additionally fasting blood samples will be obtained at month 0 3 6 9 and 12 during intervention period and at month 6 12 18 24 30 36 42 and 48 during follow-up Hematological plasma and erythrocyte PLP plasma pyridoxal and 4-pyridoxic acid serum and erythrocyte folate serum vitamin B-12 homocysteine SAM SAH lipid peroxidation indicators TBARS oxidized LDL glutathione antioxidant enzymatic activities and DNA methylation and MTHFR 677CT polymorphism will be measured
Detailed Description:
None
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