Trial record 20 of 885 for:    Open Studies | "Vitamin B Complex"

The Effects of Vitamin B-6 and Coenzyme Q10 Status on Oxidative Stress, Antioxidant Capacities, and Inflammatory Responses in Patients With Liver Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Taichung Veterans General Hospital
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01964001
First received: October 10, 2013
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

Carcinoma is the leading cause of worldwide. Hepatocellular carcinoma (HCC) is the second cause of cancer mortality in Taiwan. Vitamin B-6 and coenzyme Q10 has been recognized as antioxidants and anti-inflammatory nutrients in recent clinical studies. The purposes of this study are going to investigate the relation of vitamin B-6 and coenzyme Q10 with the indicators of oxidative stress, antioxidant enzymes activities and the inflammatory markers in patients with stage 1 and stage 2 HCC. The study is designed as an intervention study. The investigators will recruit HCC patients with stage 1 and stage 2 (n = 150) who are identified by liver biopsy. HCC subjects are randomly assign to placebo, vitamin B-6 (50 mg/d), coenzyme Q10 (300 mg/d), and vitamin B-6 plus coenzyme Q10 supplements groups. Intervention is going to administration for three months. The concentrations of vitamin B-6, coenzyme Q10, oxidative stress indicators, antioxidant enzymes activities, antioxidant vitamins (vitamin A and E), and inflammatory markers are going to be analyzed. The results would provide more information nutrients for clinical physicians and dietitians for considering suggesting patients with HCC using vitamin B-6 or coenzyme Q10 supplementation to improve their clinical outcomes.


Condition Intervention Phase
Hepatocellular Carcinoma.
Dietary Supplement: Vitamin B-6
Dietary Supplement: Coenzyme Q10
Dietary Supplement: Vitamin B-6+Coenzyme Q10
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • Antioxidant capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This study are going to measure the indicators of antioxidant capacity including Vitamin B-6, coenzyme Q10, vitamin A and E, lipid peroxidation markers (malondialdehyde), and antioxidant enzymes activities (catalase, glutathione peroxidase and superoxide dismutase).


Secondary Outcome Measures:
  • Inflammation markers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This study are going to measure the inflammation markers including C-reactive protein, Tumor necrosis factor-alfa, Interleukin-1 beta, Interleukin-6,adiponectin, homocysteine, S-adenosyl-methionine, and S-adenosyl-homocysteine.


Estimated Enrollment: 150
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
starch
Other: Placebo
starch
Experimental: Dietary supplements
Vitamin B-6/Coenzyme Q10/vitamin B6+Coenzyme Q10
Dietary Supplement: Vitamin B-6
Vitamin B-6 50 mg/d
Dietary Supplement: Coenzyme Q10
Coenzyme Q10 300 mg
Dietary Supplement: Vitamin B-6+Coenzyme Q10
Vitamin B-6 (50 mg/d) and Coenzyme Q10 (300 mg/d)

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- The HCC patients with stage 1 and stage 2 (n = 150) who are identified by liver biopsy.

Exclusion Criteria:

  • age < 20 years old.
  • The patients who had heart, renal, gestational, diabetes, or other metabolic diseases.
  • Under the medications which may interfere the vitamin B-6 or coenzyme Q10 concentrations, such as phenobarbital, phenytoin, cycloserine, pyrazinamide, isoniazid, (thio)semicarbazide, hydramitrazine, phenelzine, carbidopa, levodopa, hydralazine, steroids, penicillamine, ,Statin, or Warfarin.
  • The women who are during pregnancy or Lactation.
  • The women who are taking the oral contraceptives.
  • The subjects who are taking the dietary supplements, such as vitamin B-6, coenzyme Q10, or other antioxidant vitamins.
  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: NCT01964001

Contacts
Contact: Ping-Ting Lin, Ph.D. +886-4-24730022 ext 12187 apt810@csmu.edu.tw

Locations
Taiwan
Taichung Verterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Ping-Ting Lin, Ph.D.    +886-24730022 ext 12187    apt810@csmu.edu.tw   
Contact: Hsiao-Tien Liu, M.D.    +886-23592525 ext 5021    langhsky@vghtc.gov.tw   
Principal Investigator: Ping-Ting Lin, Ph.D.         
Sponsors and Collaborators
Taichung Veterans General Hospital
  More Information

No publications provided

Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01964001     History of Changes
Other Study ID Numbers: CF13197
Study First Received: October 10, 2013
Last Updated: February 17, 2014
Health Authority: Taiwan: Ministry of Health and Welfare

Additional relevant MeSH terms:
Vitamin B 6
Vitamin B Complex
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Pyridoxine
Pyridoxal
Ubiquinone
Coenzyme Q10
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014