NCT01964001

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Taichung Veterans General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma.

Interventions

Type	Name	Description
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)
OTHER	Placebo	starch

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2013-10-17
• Last updated: 2016-06-15

Locations

1 site across 1 country: Taiwan