Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients

Phase 2

Completed

• Conditions: Non Alcoholic Fatty Liver Disease
• Interventions: Dietary Supplement: Niacinamide Oral Tablet; Drug: Antidiabetic

• Registration Number: NCT03850886
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-15
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-22
• Primary Completion: 2019-08-07
• Study Completion: 2019-08-07
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-18
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Niacinamide group	Niacinamide Oral Tablet	Niacinamide oral tablets as Nature's Life 1000 mg tablets once daily for 3 months diabetes management including metformin or Sulphonylurea
Niacinamide group	Antidiabetic	Niacinamide oral tablets as Nature's Life 1000 mg tablets once daily for 3 months diabetes management including metformin or Sulphonylurea
Control group	Antidiabetic	diabetes management including metformin or Sulphonylurea

Primary Outcome Measures

Name	Time	Method
Steatosis using Fibroscan with CAP	3 months	using Fibroscan with CAP
Adiponectin mesurement	3 months	Endothelial dysfunction

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AlZahraa hospital; 🇪🇬 Cairo, Egypt