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Completed

NCT Number: NCT03850886

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.

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Key information

Conditions

Non Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AlZahraa hospital

Cairo, 02, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

  • Ascetic patients and congestive heart failure patients will be excluded due to unreliability of Fibroscan results in them.
  • Pregnancy and lactation.

Treatment and study plan

Niacinamide Oral Tablet

Dietary Supplement

Nature's Life Niacinamide 1000 mg

Other names: Nicotinamide, Vitamin B3

Antidiabetic

Drug

Metformin or Sulphonylurea

Primary outcomes

  1. Steatosis using Fibroscan with CAP

    Time frame: 3 months

    using Fibroscan with CAP

  2. Adiponectin mesurement

    Time frame: 3 months

    Endothelial dysfunction

Secondary outcomes

  1. Malondialdehyde

    Time frame: 3 monthes

    Oxidative stress marker

  2. HOMA-IR

    Time frame: 3 months

    Insulin resistance

  3. ALT, AST

    Time frame: 3 months

    Liver enzymes

  4. LDL, cholesterol

    Time frame: 3 months

    Lipid markers

Other outcomes

  1. Chronic Liver Disease Questionnaire

    Time frame: 3 months

    quality of measurement

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 22, 2019
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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