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

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05578404

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease	Drug: Cholecalciferol Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

double-blinded

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 20, 2022

Anticipated Primary Completion Date :

Mar 20, 2025

Anticipated Study Completion Date :

Feb 20, 2026

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Group 50 patients will receive the standard conventional therapy in addition to a placebo for 4 months.	Drug: Placebo matching placebo to Vit D
Active Comparator: Vit D Group 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 Vit D is a fat-soluble vitamin, provided by sunlight and activated by kidneys and liver.

Arm

Intervention/Treatment

Placebo Comparator: Control Group

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

Drug: Placebo

matching placebo to Vit D

Active Comparator: Vit D Group

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

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta Unuversity	Tanta		Egypt	31527

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mostafa Bahaa, Teaching Assistant, Tanta University

ClinicalTrials.gov Identifier:

NCT05578404

Other Study ID Numbers:

10/2022

First Posted:

Oct 13, 2022

Last Update Posted:

Nov 2, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Diseases

Fatty Liver

Non-alcoholic Fatty Liver Disease

Cholecalciferol

Vitamin D

Study Results

No Results Posted as of Nov 2, 2022