Alcoholic Hepatitis Clinical Trial
Official title:
Effect of Omega-5 Fatty Acid Supplement on Markers of Inflammation and Oxidative Stress in Patients With Severe Alcoholic Hepatitis Treated With Prednisone
Verified date | May 2023 |
Source | Hospital General Dr. Manuel Gea González |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In Mexico, alcoholic liver disease is the fourth cause of mortality (INEGI). Patients with severe alcoholic hepatitis have a high mortality at 28 days and 6 months, patients receiving standard therapy with prednisone that are non responders (Lille> 0.45) have a survival of 53.3 ± 5.1 % to 28 days. At present, there is not a completely effective treatment for non responders patients, with a high mortality, so it is necessary to look for other therapeutic strategies. The omega-5 fatty acid (punicic acid) has been considered a powerful antioxidant, it is an agonist of PPAR gamma, has been shown to reduce lipid peroxidation, and restore levels of antioxidant enzymes such as superoxide dismutase (SOD), catalase and glutathione peroxidase. It has also been shown to inhibit the expression of proinflammatory cytokines (such as IL6, IL8, IL23, IL12 and TNFalpha) through PPAR and modulation delta. The objective of this study is to evaluate the effect of Omega 5 fatty acid on inflammatory markers and antioxidant-oxidant balance markers in patients with severe alcoholic hepatitis treated with prednisone. HYPOTHESIS. Omega 5 fatty acid being a PPARgamma agonist reduces lipid peroxidation and protein damage, restoring reduced glutathione levels, as well as decreasing proinflammatory cytokines, in patients with Severe Alcoholic Hepatitis treated with prednisone and supplementation with fatty acid Omega 5.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 22, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients with clinical and biochemical criteria for severe alcoholic hepatitis (Total bilirubin greater than 5 mg/dl in absence of biliary tract obstruction evidenced by ultrasound) - history of chronic alcohol intake (greater than 50 g / day for at least 3 months), - leukocytosis (neutrophilia) - elevation of transaminases with an aspartate aminotransferase / alanine aminotransferase ratio equal or greater than 2) - discriminant function greater than 32. Exclusion Criteria: - Hepatorenal syndrome (serum creatinine >2.5mg/dl) - Hepatocellular carcinoma. - Hepatitis C virus, hepatitis B virus or human immunodeficiency virus infection. - Cancer, heart disease, neurological or severe neurological. - Patients taking pentoxifylline, steroids, S-adenosyl L- methionine or N-Acetylcysteine. |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital General Dr. Manuel Gea Gonzalez | Mexico City | Tlalpan |
Mexico | Laboratorio de Higado, Pancreas y Motilidad Intestinal. UNIVERSIDAD AUTONOMA DE MEXICO | Mexico City | Cuauhtemoc |
Lead Sponsor | Collaborator |
---|---|
Hospital General Dr. Manuel Gea González | Universidad Nacional Autonoma de Mexico |
Mexico,
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* Note: There are 44 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 30 Day Survival | Better survival in patients with omega 5 supplement associated to prednisone | day 30 | |
Secondary | Rate of reponse to steroids at day 7 | To describe the response to steroids (Lille score) at 7 days of treatment in patients with severe alcoholic hepatitis with combined treatment (Omega 5 and steroids) compared to standard treatment. (Lille response describe a below of 0.45) | day 7 | |
Secondary | Malondialdehyde serum levels | To determine the serum concentrations of lipid peroxidation molecules (malondialdehyde (MDA expressed in mM) in patients with severe alcoholic hepatitis treated with prednisone compare to those treated with prednisona and omega5. | basal, day 7, day 14 and day 28 | |
Secondary | Oxidative Stress molecules serum levels | To assess changes in oxidative stress markers (Oxidative glutation and reduced glutation expressed in mM) in patients with severe alcoholic hepatitis treated with prednisone compared to those treated with prednisone and omega 5. | basal, day 7, day 14 and day 28 |
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