Status:
COMPLETED
Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients
Lead Sponsor:
Ain Shams University
Conditions:
Non Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2019
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03850886
Start Date
January 15 2019
End Date
August 7 2019
Last Update
January 22 2020
Active Locations (1)
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1
AlZahraa hospital
Cairo, Egypt, 02