An interventional study of vitamin B-6 and Glutathione in Liver Cirrhosis and Liver Cancer, sponsored by Taichung Veterans General Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-12-22.
Sponsored by Taichung Veterans General Hospital · Not applicable, Interventional, and Prevention
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.
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 25 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Taichung Veterans General Hospital is the lead sponsor of 171 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dextrins
Dietary Supplement: Dextrins
50 mg/d vitamin B-6
Dietary Supplement: vitamin B-6
500 mg/d Glutathione
Dietary Supplement: Glutathione
50 mg/d vitamin B-6 plus 500 mg/d Glutathione
Dietary Supplement: vitamin B-6 · Dietary Supplement: Glutathione
50 mg/d
500 mg/d
50 mg/d
Oxidative stress marker (MDA concentation)
Time frame: 3 months
Glutathione related enzyme activities
Time frame: 3 months
This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Taichung Veterans General Hospital