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
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|ClinicalTrials.gov Identifier: NCT01426490|
Recruitment Status : Unknown
Verified August 2011 by Taichung Veterans General Hospital.
Recruitment status was: Recruiting
First Posted : August 31, 2011
Last Update Posted : February 19, 2014
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 and/or 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 and/or 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 nmol/L will be asked to participate the intervention study and will be blinded and randomly assigned to either the 1) control (vitamin C, 100 mg/d); 2) 50 mg vitamin B-6; 3) 400 microgram/d folic acid; or 4) vitamin B-6 (50 mg/d) plus folic acid (400 microgram/d) 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 677C>T polymorphism will be measured.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Dietary Supplement: Vitamin C Dietary Supplement: Vitamin B6 Dietary Supplement: Folic acid Dietary Supplement: Vitamin B6 plus folic acid||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Care Provider)|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2015|
Vitamin C as control group.
Dietary Supplement: Vitamin C
Vitamin C, 100 mg/d
Other Name: Ascorbic acid
|Experimental: Vitamin B6||
Dietary Supplement: Vitamin B6
Vitamin B6, 50mg/d
Other Name: Pyridoxine
|Experimental: Folic acid||
Dietary Supplement: Folic acid
Folic acid 400 microgram/d
Other Name: Folate
|Experimental: Vitamin B6 plus folic acid||
Dietary Supplement: Vitamin B6 plus folic acid
Vitamin B6, 50 mg; folic acid, 400 microgram
Other Name: B-vitamins (pyridoxine and folate)
- Antioxidant and DNA methylation [ Time Frame: 12 months ]This study are going to measure the oxidative stress (TBARs), antioxidant activities and DNA methylation in colorectal cancer patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426490
|Contact: Chiang Feng-Fanfirstname.lastname@example.org|
|Taichung Verterans General Hospital||Recruiting|
|Contact: Feng-Fan Chiang, MD email@example.com|