High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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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

Official Title
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The Effect of High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease Patients

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Drug: Cholecalciferol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>50 patients will receive the standard conventional therapy in addition to a placebo for 4 months. | Drug: Placebo<br>* matching placebo to Vit D<br>|
| Active Comparator: Vit D Group<br>50 patients were given the standard conventional therapy plus cholecalciferol. Cholecalciferol was given as a high oral loading dose of 300,000 IU followed by a daily oral dose of 800 IU for 4 months. | Drug: Cholecalciferol<br>* Vit D is a fat-soluble vitamin, provided by sunlight and activated by kidneys and liver.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |