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
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease
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).
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
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
No
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
Email
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
Email
.mbahaa@horus.edu.eg
First Name & Middle Initial & Last Name & Degree
Mostafa M Bahaa, PhD
12. IPD Sharing Statement
Learn more about this trial
High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease
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