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Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients

Primary Purpose

Non Alcoholic Fatty Liver Disease

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Niacinamide Oral Tablet
Antidiabetic
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • AlZahraa hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Niacinamide group

Control group

Arm Description

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

diabetes management including metformin or Sulphonylurea

Outcomes

Primary Outcome Measures

Steatosis using Fibroscan with CAP
using Fibroscan with CAP
Adiponectin mesurement
Endothelial dysfunction

Secondary Outcome Measures

Malondialdehyde
Oxidative stress marker
HOMA-IR
Insulin resistance
ALT, AST
Liver enzymes
LDL, cholesterol
Lipid markers

Full Information

First Posted
January 30, 2019
Last Updated
January 18, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03850886
Brief Title
Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients
Official Title
Evaluation of Efficacy and Safety of Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
August 7, 2019 (Actual)
Study Completion Date
August 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Niacinamide group
Arm Type
Experimental
Arm Description
Niacinamide oral tablets as Nature's Life 1000 mg tablets once daily for 3 months diabetes management including metformin or Sulphonylurea
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
diabetes management including metformin or Sulphonylurea
Intervention Type
Dietary Supplement
Intervention Name(s)
Niacinamide Oral Tablet
Other Intervention Name(s)
Nicotinamide, Vitamin B3
Intervention Description
Nature's Life Niacinamide 1000 mg
Intervention Type
Drug
Intervention Name(s)
Antidiabetic
Intervention Description
Metformin or Sulphonylurea
Primary Outcome Measure Information:
Title
Steatosis using Fibroscan with CAP
Description
using Fibroscan with CAP
Time Frame
3 months
Title
Adiponectin mesurement
Description
Endothelial dysfunction
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Malondialdehyde
Description
Oxidative stress marker
Time Frame
3 monthes
Title
HOMA-IR
Description
Insulin resistance
Time Frame
3 months
Title
ALT, AST
Description
Liver enzymes
Time Frame
3 months
Title
LDL, cholesterol
Description
Lipid markers
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Chronic Liver Disease Questionnaire
Description
quality of measurement
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
AlZahraa hospital
City
Cairo
ZIP/Postal Code
02
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
35222903
Citation
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.
Results Reference
derived

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Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients

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