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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05578404
• Other study ID #: 10/2022
• Status: Completed
• Phase: Phase 2
• Start date: October 20, 2022
• Est. completion date: April 20, 2023

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cholecalciferol
Vit D is a fat-soluble vitamin, provided by sunlight and activated by kidneys and liver.
• Placebo
matching placebo to Vit D

Locations

Country	Name	City	State
Egypt	Tanta Unuversity	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting blood glucose (FBG mg/dl)		4 months
Primary	Glycated hemoglobin (HbA1C%)		4 months
Primary	Fasting insulin (mU/L).		4 months
Primary	Alanine transaminase (ALT U/L)		4 months
Primary	Aspartate transaminase (AST U/L)		4 months
Primary	Albumin (g/dl)		4 months
Primary	Gamma-glutamyl transferase (GGT U/L)		4 months
Primary	Alkaline phosphatase (ALP U/L)		4 months
Primary	Lipid profile: Low-density lipoprotein (LDL-C mg/dl), High-density lipoprotein (HDL-C mg/dl)		4 months
Primary	Lipid profile: Triglycerides (TG mg/dl)		4 months
Primary	Lipid profile: Total cholesterol (TC mg/dl)		4 months