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Completed

NCT Number: NCT05578404

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

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

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tanta Unuversity

Tanta, 31527, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cholecalciferol

Drug

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

Placebo

Drug

matching placebo to Vit D

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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2022
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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