Effect of Omega-5 Fatty Acid Supplement on Markers of Inflammation and Oxidative Stress in Patients With Severe Alcoholic Hepatitis Treated With Prednisone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- 30 Day Survival
研究概览
简要总结
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.
详细描述
Double-blind clinical trial.
Two groups:
- GROUP A (standard treatment): Prednisone 40 mg a day + Placebo (manufactured by the same laboratory with the same presentation and physical appearance as the nanoemulsifyied pomegranate seed oil rich in Omega 5 fatty acid)
- GROUP B (combined treatment): Prednisone 40 mg per day + nanoemulsifiyied pomegranate seed oil rich in Omega 5 fatty acid (2 capsules of 0.64g each / day).
STUDY UNIVERSE: Patients> 18 years old, indistinct gender, with a diagnosis of severe alcoholic hepatitis.
STUDY POPULATION: Patients with clinical and laboratory diagnosis of alcoholic hepatitis Severe Maddrey score ≥32.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Subjects will be randomly assigned to one of the two treatments. The randomization is done through a computer generated system. The labelling will be done by a pharmacist or similar. Envelopes with randomization listings will be stored in a secure environment within the Hospital. Blinding should be maintained throughout the study. The randomization code should not be broken during the course of the study unless it is necessary for the safety of the subjects, as judged by the investigator. The date, time and reason for unmasking must be recorded, along with the researcher's signature. The rupture of the study blind will be done once the database has been blocked. The study will be double-blind, which means that neither the patients nor the study site staff will have access to the randomization code until the code is broken.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
30 Day Survival
时间窗: day 30
Better survival in patients with omega 5 supplement associated to prednisone
次要结局
- Malondialdehyde serum levels(basal, day 7, day 14 and day 28)
- Oxidative Stress molecules serum levels(basal, day 7, day 14 and day 28)
- Rate of reponse to steroids at day 7(day 7)
研究者
Jacqueline Cordova-Gallardo
Hepatologist
Hospital General Dr. Manuel Gea González