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Vitamin B-6 and Glutathione on Inflammation, Homocysteine, Oxidative Stress and Antioxidant Capacities

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ClinicalTrials.gov Identifier: NCT02321579
Recruitment Status : Unknown
Verified December 2014 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
First Posted : December 22, 2014
Last Update Posted : December 22, 2014
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital

Brief Summary:
This study is designed as a hospital-based cross-sectional and randomized placebo-controlled intervention trial. One hundred and fifty patients with either cirrhosis or cirrhosis combined with hepatocellular carcinoma (HCC) who meet the inclusion criteria will be recruited from Taichung General Veterans Hospital. One hundred patients will be randomly assigned to either the 1) placebo group (n = 25); 2) vitamin B-6 group; (50 mg/d, n = 25); 3) glutathione (GSH) group (500 mg/d, n = 25); or 4) vitamin B-6 (50 mg/d) plus GSH (500 mg/d) group (n = 25) for 3 mo. Data on demography, anthropometry and medical history will be collected. Patients with cirrhosis or cirrhosis combined with HCC will have fasting blood drawn in the clinics. Additionally, patients who participated in the intervention study will have blood drawn at month 0, 1, 2 and 3 during intervention period. Hematological measurements, plasma vitamin B-6 status, GSH, inflammatory markers, homocysteine, cysteine, SAM, SAH, oxidative stress indicator, oxidized GSH and GSH related antioxidant enzyme activities will be analyzed.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Liver Cancer Dietary Supplement: vitamin B-6 Dietary Supplement: Glutathione Dietary Supplement: Dextrins Not Applicable

Detailed Description:

Liver cirrhosis is now the ninth leading cause of death and hepatocellular carcinoma (HCC) is the second leading cause of cancer mortality among men and women in Taiwan. Vitamin B-6 and glutathione (GSH) are metabolized in liver, the role of vitamin B-6 and GSH playing in the inflammatory responses and antioxidant function would be impaired during hepatic injury. The purpose of this study is going to assess the effects of individual or combined supplementation of vitamin B-6 and GSH on homocysteine, cysteine, the ratio of S-adenosylmethionine (SAM)/S-adenosylhomocysteine (SAH), oxidative stress, oxidized glutathione (GSSG) and GSH related antioxidant enzyme activities in patients with cirrhosis and cirrhosis combined with HCC.

This study is designed as a hospital-based cross-sectional and randomized placebo-controlled intervention trial. One hundred and fifty patients with either cirrhosis or cirrhosis combined with HCC who meet the inclusion criteria will be recruited from Taichung General Veterans Hospital. One hundred patients will be randomly assigned to either the 1) placebo group (n = 25); 2) vitamin B-6 group; (50 mg/d, n = 25); 3) GSH group (500 mg/d, n = 25); or 4) vitamin B-6 (50 mg/d) plus GSH (500 mg/d) group (n = 25) for 3 mo. Data on demography, anthropometry and medical history will be collected. Patients with cirrhosis or cirrhosis combined with HCC will have fasting blood drawn in the clinics. Additionally, patients who participated in the intervention study will have blood drawn at month 0, 1, 2 and 3 during intervention period. Hematological, plasma vitamin B-6 status, GSH, inflammatory markers, homocysteine, cysteine, SAM, SAH, oxidative stress indicator, GSSG and GSH related antioxidant enzyme activities will be measured.

Hopefully, the results of this study could provide more pictures on the beneficial effects of vitamin B-6 and GSH supplementation on inflammatory responses, homocysteine, cysteine, the ratio of SAM/SAH, oxidative stress, GSSG and GSH related antioxidant enzyme activities in patients with cirrhosis and HCC.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: The Effects of Vitamin B-6 and Glutathione on Inflammatory Responses, Homocysteine Metabolism, Oxidative Stress and Antioxidant Capacities in Patients With Liver Cirrhosis or Hepatocellular Carcinoma
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : July 2017


Arm Intervention/treatment
Placebo Comparator: Negative control
Dextrins
Dietary Supplement: Dextrins
50 mg/d

Experimental: Supplement 1
50 mg/d vitamin B-6
Dietary Supplement: vitamin B-6
50 mg/d

Experimental: Supplement 2
500 mg/d Glutathione
Dietary Supplement: Glutathione
500 mg/d

Experimental: Supplement 3
50 mg/d vitamin B-6 plus 500 mg/d Glutathione
Dietary Supplement: vitamin B-6
50 mg/d

Dietary Supplement: Glutathione
500 mg/d




Primary Outcome Measures :
  1. Oxidative stress marker (MDA concentation) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Glutathione related enzyme activities [ Time Frame: 3 months ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age between 20 to 80 years old
  2. patients are diagnosed as cirrhosis or cirrhosis combined with hepatocellular carcimoma

Exclusion Criteria:

  1. patients are currently taking any nutrient supplements
  2. patients with cardiac, renal, gastrointestinal or diabetic diseases
  3. patients are currently taking any medication which will interfere with vitamin B-6 or glutathione metabolism〔i.e., phenobarbital, phenytoin, cycloserine, pyrazinamide, isoniazid, (thio)semicarbazide, hydramitrazine, phenelzine, carbidopa, levodopa, hydralazine, steroids and penicillamine)
  4. patients are in pregnant or lactation.

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): NCT02321579


Contacts
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Contact: Yi-Chia Huang, PhD +886-4-24730022 ext 12198 ych@csmu.edu.tw

Locations
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Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Yi-Chia Huang, PhD    +886-4-24730022 ext 12198    ych@csmu.edu.tw   
Principal Investigator: Shao-Bin Cheng, MD         
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
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Principal Investigator: Shao-Bin Cheng, MD Taichung Veterans General Hospital

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Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT02321579     History of Changes
Other Study ID Numbers: SF14261B
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: December 22, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Liver Neoplasms
Pathologic Processes
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Vitamins
Vitamin B 6
Pyridoxal
Pyridoxine
Vitamin B Complex
Antioxidants
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents