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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 has been completed.
Information provided by (Responsible Party):
Taichung Veterans General Hospital Identifier:
First received: October 10, 2013
Last updated: June 14, 2016
Last verified: June 2016
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.

Enrollment: 71
Study Start Date: January 2014
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Other: Placebo
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)


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01964001

Taichung Verterans General Hospital
Taichung, Taiwan, 40705
Sponsors and Collaborators
Taichung Veterans General Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Taichung Veterans General Hospital Identifier: NCT01964001     History of Changes
Other Study ID Numbers: CF13197 
Study First Received: October 10, 2013
Last Updated: June 14, 2016
Health Authority: Taiwan: Ministry of Health and Welfare

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Coenzyme Q10
Vitamin B 6
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on October 25, 2016