Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients

Non Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03850886
• Other study ID #: PHCL79
• Status: Completed
• Phase: Phase 2
• Start date: January 15, 2019
• Est. completion date: August 7, 2019

Study information

• Verified date: January 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 7, 2019
• Est. primary completion date: August 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non Alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Niacinamide Oral Tablet
Nature's Life Niacinamide 1000 mg

Drug:
• Antidiabetic
Metformin or Sulphonylurea

Locations

Country	Name	City	State
Egypt	AlZahraa hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chronic Liver Disease Questionnaire	quality of measurement	3 months
Primary	Steatosis using Fibroscan with CAP	using Fibroscan with CAP	3 months
Primary	Adiponectin mesurement	Endothelial dysfunction	3 months
Secondary	Malondialdehyde	Oxidative stress marker	3 monthes
Secondary	HOMA-IR	Insulin resistance	3 months
Secondary	ALT, AST	Liver enzymes	3 months
Secondary	LDL, cholesterol	Lipid markers	3 months