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

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status

Recruiting

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Cholecalciferol

Placebo

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Tanta UnuversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control Group

Vit D Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Fasting blood glucose (FBG mg/dl)

Glycated hemoglobin (HbA1C%)

Fasting insulin (mU/L).

Alanine transaminase (ALT U/L)

Aspartate transaminase (AST U/L)

Albumin (g/dl)

Gamma-glutamyl transferase (GGT U/L)

Alkaline phosphatase (ALP U/L)

Lipid profile: Low-density lipoprotein (LDL-C mg/dl), High-density lipoprotein (HDL-C mg/dl)

Lipid profile: Triglycerides (TG mg/dl)

Lipid profile: Total cholesterol (TC mg/dl)

Secondary Outcome Measures

Full Information

NCT ID

NCT05578404

First Posted

October 8, 2022

Last Updated

October 30, 2022

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT05578404

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 20, 2022 (Actual)

Primary Completion Date

March 20, 2025 (Anticipated)

Study Completion Date

February 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Masking Description

double-blinded

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Vit D Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

matching placebo to Vit D

Primary Outcome Measure Information:

Title

Fasting blood glucose (FBG mg/dl)

Time Frame

4 months

Title

Glycated hemoglobin (HbA1C%)

Time Frame

4 months

Title

Fasting insulin (mU/L).

Time Frame

4 months

Title

Alanine transaminase (ALT U/L)

Time Frame

4 months

Title

Aspartate transaminase (AST U/L)

Time Frame

4 months

Title

Albumin (g/dl)

Time Frame

4 months

Title

Gamma-glutamyl transferase (GGT U/L)

Time Frame

4 months

Title

Alkaline phosphatase (ALP U/L)

Time Frame

4 months

Title

Lipid profile: Low-density lipoprotein (LDL-C mg/dl), High-density lipoprotein (HDL-C mg/dl)

Time Frame

4 months

Title

Lipid profile: Triglycerides (TG mg/dl)

Time Frame

4 months

Title

Lipid profile: Total cholesterol (TC mg/dl)

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mostafa M Bahaa, PhD

Phone

0201025538337

mostafabahaamnf@gmail.com

Facility Information:

Facility Name

Tanta Unuversity

City

Tanta

ZIP/Postal Code

31527

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eman I Elberri, PhD

Phone

0201003592593

.mbahaa@horus.edu.eg

First Name & Middle Initial & Last Name & Degree

Mostafa M Bahaa, PhD

12. IPD Sharing Statement

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

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