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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by Taichung Veterans General Hospital
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01426490
First received: August 29, 2011
Last updated: February 17, 2014
Last verified: August 2011
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • Antioxidant and DNA methylation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    This study are going to measure the oxidative stress (TBARs), antioxidant activities and DNA methylation in colorectal cancer patients


Estimated Enrollment: 300
Study Start Date: August 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Vitamin C
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)

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Colorectal cancer participants were identified by colonoscopy to have at least one historically confirmed colorectal cancer.

Exclusion Criteria:

  • Age<18 years
  • Pregnant women
  • Had a history of colorectal cancer
  • Attenuated adenomatous polyposis coli
  • Inflammatory bowel disease or were taking any medication which could influence homocysteine, folate, vitamin B6 and B12 status, such as H2 blockers, Proton pump inhibitors, metformin, phenytoin, methotrexates.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426490

Contacts
Contact: Chiang Feng-Fan +886-919-710446 hankel.chiang@gmail.com

Locations
Taiwan
Taichung Verterans General Hospital Recruiting
Taichung, Taiwan
Contact: Feng-Fan Chiang, MD       hankel.chiang@gmail.com   
Sponsors and Collaborators
Taichung Veterans General Hospital
  More Information

No publications provided

Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01426490     History of Changes
Other Study ID Numbers: S10251
Study First Received: August 29, 2011
Last Updated: February 17, 2014
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Ascorbic Acid
Folic Acid
Pyridoxal
Pyridoxine
Vitamin B 6
Vitamin B Complex
Vitamins
Antioxidants
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014