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Completed

NCT Number: NCT01964001

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Taichung Verterans General Hospital

Taichung, 40705, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin B-6

Dietary Supplement

Vitamin B-6 50 mg/d

Coenzyme Q10

Dietary Supplement

Coenzyme Q10 300 mg

Vitamin B-6+Coenzyme Q10

Dietary Supplement

Vitamin B-6 (50 mg/d) and Coenzyme Q10 (300 mg/d)

Placebo

Other

starch

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 17, 2013
Registry last updated
Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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