Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Non Alcoholic Fatty Liver Disease

Treatments: Dietary Supplement: Niacinamide Oral Tablet; Drug: Antidiabetic

Study type: Interventional

Funder types: Other

Identifiers

NCT03850886

PHCL79

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Niacinamide group

Experimental group

Description:

Niacinamide oral tablets as Nature's Life 1000 mg tablets once daily for 3 months diabetes management including metformin or Sulphonylurea

Treatment:

Drug: Antidiabetic

Dietary Supplement: Niacinamide Oral Tablet

Control group

Active Comparator group

Description:

diabetes management including metformin or Sulphonylurea

Treatment:

Drug: Antidiabetic