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

Phase 2

Completed

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Drug: Placebo; Drug: Cholecalciferol

• Registration Number: NCT05578404
• Lead Sponsor: Tanta University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-08
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-13
• Study Start: 2022-10-20
• Primary Completion: 2023-04-20
• Study Completion: 2023-04-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	50 patients will receive the standard conventional therapy in addition to a placebo for 4 months.
Vit D Group	Cholecalciferol	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.

Primary Outcome Measures

Name	Time	Method
Fasting blood glucose (FBG mg/dl)	4 months
Glycated hemoglobin (HbA1C%)	4 months
Fasting insulin (mU/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
Alanine transaminase (ALT U/L)	4 months

Trial Locations

Locations (1)

Tanta Unuversity; 🇪🇬 Tanta, Egypt