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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

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ClinicalTrials.gov Identifier: NCT01964001
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : June 15, 2016
Information provided by (Responsible Party):
Taichung Veterans General Hospital

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : January 2014
Primary Completion Date : May 2016
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Antioxidant capacity [ Time Frame: 12 weeks ]
    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 :
  1. Inflammation markers [ Time Frame: 12 weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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): NCT01964001

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01964001     History of Changes
Other Study ID Numbers: CF13197
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016

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