Liver Cancer Clinical Trial
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
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
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