Non-Alcoholic Fatty Liver Disease
Conditions
Brief summary
Non-alcoholic fatty liver disease (NAFLD) is a metabolic disorder with high prevalence in patients suffering from chronic liver diseases \[1\]. NAFLD is characterized by the accumulation of \> 5% of fat deposits in hepatocytes (hepatic steatosis) with no known other reasons for steatosis as excessive alcohol intake.The global prevalence of NAFLD differs depending on the population reaching 13% in Africa, 32% in the Middle East, and 30 % in the United States
Interventions
DRUGCholecalciferol
Vit D is a fat-soluble vitamin, provided by sunlight and activated by kidneys and liver.
DRUGPlacebo
matching placebo to Vit D
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
double-blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Either male or female adult patients (\>19 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (US) and with type II diabetes diagnosed according to American Diabetes Association (ADA) 2019 criteria and treated with metformin
Exclusion criteria
* pregnant and/or lactating women, excessive alcohol use (defined as an average alcohol intake of\> 30 g per day in men and \> 20 g per day in women), * Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, patients suffering from chronic kidney disease, and hyper/hypoparathyroidism. * Hypersensitivity to cholecalciferol, hypercalcemia, patients taking supplementation with vitamin D, and calcium. * Medications affecting calcium/vitamin D metabolism (as anticonvulsants, glucocorticoids, and antacids).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood glucose (FBG mg/dl) | 4 months |
| Glycated hemoglobin (HbA1C%) | 4 months |
| Fasting insulin (mU/L). | 4 months |
| Alanine transaminase (ALT U/L) | 4 months |
| Aspartate transaminase (AST U/L) | 4 months |
| Albumin (g/dl) | 4 months |
| Gamma-glutamyl transferase (GGT U/L) | 4 months |
| Alkaline phosphatase (ALP U/L) | 4 months |
| Lipid profile: Low-density lipoprotein (LDL-C mg/dl), High-density lipoprotein (HDL-C mg/dl) | 4 months |
| Lipid profile: Triglycerides (TG mg/dl) | 4 months |
| Lipid profile: Total cholesterol (TC mg/dl) | 4 months |
Countries
Egypt
Outcome results
None listed