Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients

January 18, 2020 updated by: Rasha Roshdy Ibrahim El-kady, Ain Shams University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • AlZahraa hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 3 months
using Fibroscan with CAP
3 months
Adiponectin mesurement
Time Frame: 3 months
Endothelial dysfunction
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Malondialdehyde
Time Frame: 3 monthes
Oxidative stress marker
3 monthes
HOMA-IR
Time Frame: 3 months
Insulin resistance
3 months
ALT, AST
Time Frame: 3 months
Liver enzymes
3 months
LDL, cholesterol
Time Frame: 3 months
Lipid markers
3 months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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