Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients

Ain Shams University61 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non Alcoholic Fatty Liver Disease

Interventions

Niacinamide Oral TabletDIETARY_SUPPLEMENT

Nature's Life Niacinamide 1000 mg

AntidiabeticDRUG

Metformin or Sulphonylurea

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

AlZahraa hospital

Cairo, Egypt

Outcomes

Primary Outcomes

Steatosis using Fibroscan with CAP

using Fibroscan with CAP

Time frame: 3 months

Adiponectin mesurement

Endothelial dysfunction

Time frame: 3 months

Secondary Outcomes

Malondialdehyde

Oxidative stress marker

Time frame: 3 monthes

HOMA-IR

Insulin resistance

Time frame: 3 months

ALT, AST

Liver enzymes

Time frame: 3 months

LDL, cholesterol

Lipid markers

Time frame: 3 months

Data from ClinicalTrials.gov

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