Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT03850886

Collaborator

(none)

Enrollment

Location

Arms

6.7

Actual Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Fatty Liver Disease	Dietary Supplement: Niacinamide Oral Tablet Drug: Antidiabetic	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 15, 2019

Actual Primary Completion Date :

Aug 7, 2019

Actual Study Completion Date :

Aug 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Niacinamide group 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 Nature's Life Niacinamide 1000 mg Other Names: Nicotinamide Vitamin B3 Drug: Antidiabetic Metformin or Sulphonylurea
Active Comparator: Control group diabetes management including metformin or Sulphonylurea	Drug: Antidiabetic Metformin or Sulphonylurea

Arm

Intervention/Treatment

Experimental: Niacinamide group

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

Nature's Life Niacinamide 1000 mg

Other Names:

Nicotinamide

Vitamin B3

Drug: Antidiabetic

Metformin or Sulphonylurea

Active Comparator: Control group

diabetes management including metformin or Sulphonylurea

Drug: Antidiabetic

Metformin or Sulphonylurea

Outcome Measures

Primary Outcome Measures

Steatosis using Fibroscan with CAP [3 months]
using Fibroscan with CAP
Adiponectin mesurement [3 months]
Endothelial dysfunction

Secondary Outcome Measures

Malondialdehyde [3 monthes]
Oxidative stress marker
HOMA-IR [3 months]
Insulin resistance
ALT, AST [3 months]
Liver enzymes
LDL, cholesterol [3 months]
Lipid markers

Other Outcome Measures

Chronic Liver Disease Questionnaire [3 months]
quality of measurement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

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.