Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Efficacy and Safety of Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients

Conditions
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Non Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Dietary Supplement: Niacinamide Oral Tablet
* Drug: Antidiabetic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Niacinamide group<br>Niacinamide oral tablets as Nature's Life 1000 mg tablets once daily for 3 months diabetes management including metformin or Sulphonylurea | Dietary Supplement: Niacinamide Oral Tablet<br>* Nature's Life Niacinamide 1000 mg<br>* Other names: Vitamin B3;Drug: Antidiabetic<br>* Metformin or Sulphonylurea<br>|
| Active Comparator: Control group<br>diabetes management including metformin or Sulphonylurea | Drug: Antidiabetic<br>* Metformin or Sulphonylurea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steatosis using Fibroscan with CAP | using Fibroscan with CAP | 3 months | 
| Adiponectin mesurement | Endothelial dysfunction | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malondialdehyde | Oxidative stress marker | 3 monthes | 
| HOMA-IR | Insulin resistance | 3 months | 
| ALT, AST | Liver enzymes | 3 months | 
| LDL, cholesterol | Lipid markers | 3 months |