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

Tanta University

Status and phase: Completed; Phase 2

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Drug: Cholecalciferol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05578404

10/2022

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Vit D Group

Active Comparator group

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.

Treatment:

Drug: Cholecalciferol