A Phase 2 interventional study of Niacinamide Oral Tablet and Antidiabetic in Non Alcoholic Fatty Liver Disease, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 61 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
History of alcohol abuse (as defined by an average daily consumption of alcohol > 30 g/day in men and > 20 g/day in women).
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.
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 · Drug: Antidiabetic
diabetes management including metformin or Sulphonylurea
Drug: Antidiabetic
Nature's Life Niacinamide 1000 mg
Also known as: Nicotinamide, Vitamin B3
Metformin or Sulphonylurea
Steatosis using Fibroscan with CAP
using Fibroscan with CAP
Time frame: 3 months
Adiponectin mesurement
Endothelial dysfunction
Time frame: 3 months
Malondialdehyde
Oxidative stress marker
Time frame: 3 monthes
HOMA-IR
Insulin resistance
Time frame: 3 months
ALT, AST
Liver enzymes
Time frame: 3 months
LDL, cholesterol
Lipid markers
Time frame: 3 months
Chronic Liver Disease Questionnaire
quality of measurement
Time frame: 3 months
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ain Shams University