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

NCT05578404 | Completed Phase 2

• 1 other identifier: 10/2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

Control Group

PLACEBO COMPARATOR

50 patients will receive the standard conventional therapy in addition to a placebo for 4 months.

Drug: Placebo

Vit D Group

ACTIVE COMPARATOR

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

Interventions

Cholecalciferol DRUG

Vit D is a fat-soluble vitamin, provided by sunlight and activated by kidneys and liver.

Vit D Group

Placebo DRUG

matching placebo to Vit D

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta Unuversity

Tanta, 31527, Egypt

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 13, 2022
• Study Start: October 20, 2022
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

EG (1)