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

NCT01426490 | Unknown Phase 2 DMC

• 1 other identifier: S10251
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Antioxidant and DNA methylation

  This study are going to measure the oxidative stress (TBARs), antioxidant activities and DNA methylation in colorectal cancer patients

  12 months

Study Arms (4)

Vitamin C

OTHER

Vitamin C as control group.

Dietary Supplement: Vitamin C

Vitamin B6

EXPERIMENTAL

Dietary Supplement: Vitamin B6

Folic acid

EXPERIMENTAL

Dietary Supplement: Folic acid

Vitamin B6 plus folic acid

EXPERIMENTAL

Dietary Supplement: Vitamin B6 plus folic acid

Interventions

Vitamin C DIETARY_SUPPLEMENT

Vitamin C, 100 mg/d

Also known as: Ascorbic acid

Vitamin C

Vitamin B6 DIETARY_SUPPLEMENT

Vitamin B6, 50mg/d

Also known as: Pyridoxine

Vitamin B6

Folic acid DIETARY_SUPPLEMENT

Folic acid 400 microgram/d

Also known as: Folate

Folic acid

Vitamin B6 plus folic acid DIETARY_SUPPLEMENT

Vitamin B6, 50 mg; folic acid, 400 microgram

Also known as: B-vitamins (pyridoxine and folate)

Vitamin B6 plus folic acid

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Verterans General Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Ascorbic Acid; Vitamin B 6; Pyridoxine; Folic Acid

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Chiang Feng-Fan

CONTACT

+886-919-710446; hankel.chiang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: August 31, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 19, 2014

Record last verified: 2011-08

Locations

TW (1)