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

NCT ID: NCT05578404

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-20

Study Completion Date

2023-04-20

Brief Summary

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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

Detailed Description

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Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
double-blinded

Study Groups

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Control Group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo to Vit D

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.

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

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

Interventions

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Cholecalciferol

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

Intervention Type DRUG

Placebo

matching placebo to Vit D

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Bahaa

Teaching Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta Unuversity

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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10/2022

Identifier Type: -

Identifier Source: org_study_id