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Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients

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ClinicalTrials.gov Identifier: NCT03850886
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Rasha Roshdy Ibrahim El-kady, 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.

Condition or disease Intervention/treatment Phase
Non Alcoholic Fatty Liver Disease Dietary Supplement: Niacinamide Oral Tablet Drug: Antidiabetic Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019


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:
  • Nicotinamide
  • Vitamin B3

Drug: Antidiabetic
Metformin or Sulphonylurea

Active Comparator: Control group
diabetes management including metformin or Sulphonylurea
Drug: Antidiabetic
Metformin or Sulphonylurea




Primary Outcome Measures :
  1. Steatosis using Fibroscan with CAP [ Time Frame: 3 months ]
    using Fibroscan with CAP

  2. Adiponectin mesurement [ Time Frame: 3 months ]
    Endothelial dysfunction


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Chronic Liver Disease Questionnaire [ Time Frame: 3 months ]
    quality of measurement



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850886


Contacts
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Contact: Rasha El-kady, MD 01000252142 rashael-kady@pharma.asu.edu.eg

Locations
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Egypt
AlZahraa hospital Recruiting
Cairo, Egypt, 02
Contact: Rasha El-kady         
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Rasha Roshdy Ibrahim El-kady, Teaching assisstant at department clinical pharmacy, Ain Shams University
ClinicalTrials.gov Identifier: NCT03850886     History of Changes
Other Study ID Numbers: PHCL79
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019

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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
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Niacinamide
Niacin
Nicotinic Acids
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents