Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients

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

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 Overview

• Status: Completed
• Conditions: Non Alcoholic Fatty Liver Disease
• Intervention / Treatment: Dietary supplement: Niacinamide Oral Tablet; Drug: Antidiabetic

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • AlZahraa hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: Vitamin B3; Nicotinamide; Drug: Antidiabetic; Metformin or Sulphonylurea
Active Comparator: Control group; diabetes management including metformin or Sulphonylurea	Drug: Antidiabetic; Metformin or Sulphonylurea

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic Liver Disease Questionnaire	quality of measurement	3 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General Publications

• El-Kady RR, Ali AK, El Wakeel LM, Sabri NA, Shawki MA. Nicotinamide supplementation in diabetic nonalcoholic fatty liver disease patients: randomized controlled trial. Ther Adv Chronic Dis. 2022 Feb 23;13:20406223221077958. doi: 10.1177/20406223221077958. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): August 7, 2019
• Study Completion (Actual): August 7, 2019

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 18, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Hypoglycemic Agents; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: PHCL79

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes