Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients

Overview

The purpose of the study is to evaluate the efficacy and safety of Niacinamide supplementation on clinical outcome of fatty liver patients having type II DM through measurement of the following before and after Niacinamide administration: Liver enzymes, Lipid profie, HOMA-IR, Oxidative stress markers and endothelial dysfunction marker. Fibroscan with CAP will be done at baseline and at the end of the trial. Also, Evaluation of quality of life of patients before and after Niacinamide administration using Chronic Liver Disease questionnaire.

Full Title of Study: “Evaluation of Efficacy and Safety of Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 7, 2019

Interventions

  • Dietary Supplement: Niacinamide Oral Tablet
    • Nature’s Life Niacinamide 1000 mg
  • Drug: Antidiabetic
    • Metformin or Sulphonylurea

Arms, Groups and Cohorts

  • Experimental: Niacinamide group
    • Niacinamide oral tablets as Nature’s Life 1000 mg tablets once daily for 3 months diabetes management including metformin or Sulphonylurea
  • Active Comparator: Control group
    • diabetes management including metformin or Sulphonylurea

Clinical Trial Outcome Measures

Primary Measures

  • Steatosis using Fibroscan with CAP
    • Time Frame: 3 months
    • using Fibroscan with CAP
  • Adiponectin mesurement
    • Time Frame: 3 months
    • Endothelial dysfunction

Secondary Measures

  • Malondialdehyde
    • Time Frame: 3 monthes
    • Oxidative stress marker
  • HOMA-IR
    • Time Frame: 3 months
    • Insulin resistance
  • ALT, AST
    • Time Frame: 3 months
    • Liver enzymes
  • LDL, cholesterol
    • Time Frame: 3 months
    • Lipid markers

Participating in This Clinical Trial

Inclusion Criteria

  • 1. Male or female outpatients age 18 to 70 years old. 2. The diagnosis of NAFLD will be established according to the appearance of fatty liver on US or elevated liver enzymes (>1.5 times normal level). Exclusion Criteria:

  • 1. History of alcohol abuse (as defined by an average daily consumption of alcohol > 30 g/day in men and > 20 g/day in women). 2. Cirrhotic patients. – Fibroscan result > 12Kpa or as – predicted from FIB 4 score > 3.25 FIB-4 = age (yr) * AST (IU/L)/platelet count (109/L) * ALT1/2 (IU/L) 3. Hyper / hypoparathyroidism. 4. Cancer. 5. Viral hepatitis. 6. Biliary disease. 7. Autoimmune hepatitis 8. Other causes of liver disease (hemochromatosis, Wilson's disease). 9. Participants who took antibiotics, probiotic supplements and/or hepatotoxic medicines (NSAIDs, Amiodarone and methotrexate) within 6 months before the start of the study and during the study. 10. Ascetic patients and congestive heart failure patients will be excluded due to unreliability of Fibroscan results in them. 11. Pregnancy and lactation.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rasha Roshdy Ibrahim El-kady, Teaching assisstant at department clinical pharmacy – Ain Shams University

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