The Effects of Vitamin B-6 and Coenzyme Q10 Status on Oxidative Stress, Antioxidant Capacities, and Inflammatory Responses in Patients With Liver Cancer
Primary Purpose
Hepatocellular Carcinoma.
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Vitamin B-6
Coenzyme Q10
Vitamin B-6+Coenzyme Q10
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hepatocellular Carcinoma.
Eligibility Criteria
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.
Sites / Locations
- Taichung Verterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Dietary supplements
Arm Description
starch
Vitamin B-6/Coenzyme Q10/vitamin B6+Coenzyme Q10
Outcomes
Primary Outcome Measures
Antioxidant capacity
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
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.
Full Information
NCT ID
NCT01964001
First Posted
October 10, 2013
Last Updated
June 14, 2016
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01964001
Brief Title
The Effects of Vitamin B-6 and Coenzyme Q10 Status on Oxidative Stress, Antioxidant Capacities, and Inflammatory Responses in Patients With Liver Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma.
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
starch
Arm Title
Dietary supplements
Arm Type
Experimental
Arm Description
Vitamin B-6/Coenzyme Q10/vitamin B6+Coenzyme Q10
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin B-6
Intervention Description
Vitamin B-6 50 mg/d
Intervention Type
Dietary Supplement
Intervention Name(s)
Coenzyme Q10
Intervention Description
Coenzyme Q10 300 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin B-6+Coenzyme Q10
Intervention Description
Vitamin B-6 (50 mg/d) and Coenzyme Q10 (300 mg/d)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
starch
Primary Outcome Measure Information:
Title
Antioxidant capacity
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Inflammation markers
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Taichung Verterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
27716246
Citation
Liu HT, Huang YC, Cheng SB, Huang YT, Lin PT. Effects of coenzyme Q10 supplementation on antioxidant capacity and inflammation in hepatocellular carcinoma patients after surgery: a randomized, placebo-controlled trial. Nutr J. 2016 Oct 6;15(1):85. doi: 10.1186/s12937-016-0205-6.
Results Reference
derived
PubMed Identifier
27051670
Citation
Cheng SB, Lin PT, Liu HT, Peng YS, Huang SC, Huang YC. Vitamin B-6 Supplementation Could Mediate Antioxidant Capacity by Reducing Plasma Homocysteine Concentration in Patients with Hepatocellular Carcinoma after Tumor Resection. Biomed Res Int. 2016;2016:7658981. doi: 10.1155/2016/7658981. Epub 2016 Mar 9.
Results Reference
derived
Learn more about this trial
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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