Effect of Omega 5 Fatty Acid as an Adyuvant Treatment to Prednisone in Patients With Severe Alcoholic Hepatitis
Condition: Alcoholic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Alcoholic
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      SAMPLE SIZE: Double-blind clinical trial, which will include 20 patients for standard
      treatment and 20 patients for combined treatment, patients who meet the inclusion criteria
      will be invited to participate. If they agree to participate (after signing the informed
      consent), the AUDIT C and CAGE questionnaires will be applied, as well as the measurement of
      anthropometric values and the taking of 3 blood tubes (2 purple and 1 yellow) for the
      measurement of cytokines, markers of oxidative stress, lipid peroxidation and protein
      carbonyls.

      The initial evaluation will include liver ultrasound, heart rate, blood pressure,
      temperature, anthropometric evaluation (weight (kilograms), height (meters), BMI (kg/m2),
      evaluation of ascites (abdominal circumference), hepatic encephalopathy (West Haven Scale).
      Alcohol abuse will be assessed using the AUDIT and CAGE score. Start-up laboratories will be
      carried out: TP, INR, Complete liver function tests (BT, BD, FA, AST, ALT, GGT, Albumin),
      Seric electrolytes (Na, K, Phosphorus, Magnesium), Creatinine, Blood cytometry (Leukocytes
      (PMN) ), hemoglobin, VCM, platelets), lipid profile (ColT, HDL, LDL, TGs), ferritin and
      transferrin saturation, Anti-nuclear antibodies, Anti mithochondrial antibodies, AgHBs,
      AcHBc, anti HCV, anti HIV. The scrutiny of bacterial infections will be carried out through
      urine culture, blood cultures and in case of suspicion of SBP (paracenthesis). Child-Pugh
      score (A5-6, B7-9, C10-12), Maddrey score, MELD, ABIC score, Glasgow score. Chest x-Ray,
      General Urine Test.

      Patients who meet the inclusion criteria, previously described, will be proposed to
      participate in the study, explaining in detail the procedures as well as the studiesthat will
      be performed. If they agree to participate, they will proceed to the signature of the
      informed consent by the patient and their responsible family member. Samples (2 yellow tubes
      and 2 purple tubes) will be taken for the measurement of cytokines, markers of oxidative
      stress, lipid peroxidation and protein carbonyls prior to the supply of the supplement vs
      placebo as well as the start of standard treatment. It will be explained to the patient that
      these samples will be done in 4 times (at diagnosis, on day 7, 14 and 28), which will be
      carried out during their hospitalization and follow-up.

      Both treatments will be taken for 28 days.
    

Intervention name(s): Omega 5 fatty acid supplement; PLACEBO
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Patients will be randomized to receive traditional treatment (prednisone 40 mg per day) plus omega 5 fatty acid ( 2 capsules of 0.64g per day) for 28 days.; Patients will be randomized to receive the traditional treatment (prednisone 40 mg per day) plus placebo (2 capsules of placebo with identical appereance and size like omega 5 supplement) for 28 days.
Other intervention name(s): placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-blind clinical trial.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Severe Alcoholic Hepatitis treatment