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CompletedNCT05578404Updated Nov 29, 2023

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

A Phase 2 interventional study of Cholecalciferol and Placebo in Non-Alcoholic Fatty Liver Disease, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by Tanta University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Non-Alcoholic Fatty Liver Disease
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 100 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (actual)

Study arms

  • Placebo comparator
    Control Group

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

    Drug: Placebo

  • 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

Interventions

  • DrugCholecalciferol

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

  • DrugPlacebo

    matching placebo to Vit D

06

What researchers measure

Primary outcomes

  1. Fasting blood glucose (FBG mg/dl)

    Time frame: 4 months

  2. Glycated hemoglobin (HbA1C%)

    Time frame: 4 months

  3. Fasting insulin (mU/L).

    Time frame: 4 months

  4. Alanine transaminase (ALT U/L)

    Time frame: 4 months

  5. Aspartate transaminase (AST U/L)

    Time frame: 4 months

  6. Albumin (g/dl)

    Time frame: 4 months

  7. Gamma-glutamyl transferase (GGT U/L)

    Time frame: 4 months

  8. Alkaline phosphatase (ALP U/L)

    Time frame: 4 months

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

    Time frame: 4 months

  10. Lipid profile: Triglycerides (TG mg/dl)

    Time frame: 4 months

  11. Lipid profile: Total cholesterol (TC mg/dl)

    Time frame: 4 months

07

Study locations

1 site
  • Tanta Unuversity
    Tanta, 31527, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05578404
Lead sponsor
Tanta University
Responsible party
Mostafa Bahaa (Teaching Assistant, Tanta University) — Principal investigator
First posted
Oct 13, 2022
Start date
Oct 20, 2022
Primary completion
Apr 20, 2023
Completion
Apr 20, 2023
Last update
Nov 29, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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