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

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma.
• Interventions: Dietary Supplement: Vitamin B-6; Other: Placebo; Dietary Supplement: Coenzyme Q10; Dietary Supplement: Vitamin B-6+Coenzyme Q10

• Registration Number: NCT01964001
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-13
• Study First Posted: 2013-10-17
• Study Start: 2014-01
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary supplements	Vitamin B-6	Vitamin B-6/Coenzyme Q10/vitamin B6+Coenzyme Q10
Dietary supplements	Vitamin B-6+Coenzyme Q10	Vitamin B-6/Coenzyme Q10/vitamin B6+Coenzyme Q10
Placebo	Placebo	starch
Dietary supplements	Coenzyme Q10	Vitamin B-6/Coenzyme Q10/vitamin B6+Coenzyme Q10

Primary Outcome Measures

Name	Time	Method
Antioxidant capacity	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

Name	Time	Method
Inflammation markers	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.

Trial Locations

Locations (1)

Taichung Verterans General Hospital; 🇨🇳 Taichung, Taiwan