Effectiveness of Inactive Vitamin D Supplementation in Non-Alcoholic Fatty Liver Disease Patients

NCT05613192 | Unknown Phase 3 DMC

• 1 other identifier: NHTMRI-IRB 10-22
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of work The aim of our study is to assess the effectiveness and safety of high oral loading dose of inactive vitamin D supplementation on the clinical parameters related to liver steatosis, glycaemic control, insulin resistance and metabolic profile in NAFLD patients

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

non-alcoholic fatty liver- vitamin D

Outcome Measures

Primary Outcomes (1)

• Efficacy of cholecalciferol on glycaemic control parameters in non alcoholic fatty liver disease

  Decrease in glycated haemoglobin in NAFLD patients

  at Baseline and at week 16

Secondary Outcomes (1)

• Efficacy of cholecalciferol on the degree of steatosis in non alcoholic fatty liver disease

  at Baseline and at week 16

Study Arms (2)

Placebo

ACTIVE COMPARATOR

Group 1: patients receive the standard conventional therapy in addition to placebo for 4 months.

Drug: Cholecalciferol

Cholecalciferol

EXPERIMENTAL

Group 2: patients receive the standard conventional therapy in addition to a single oral dose of cholecalciferol 300,000 IU followed by oral cholecalciferol 800 IU daily for 4 months.

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

patients receive the standard conventional therapy in addition to a single oral dose of cholecalciferol 300,000 IU followed by oral cholecalciferol 800 IU daily for 4 months.

Also known as: native vitamin D

Cholecalciferol; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients \>18 years with fatty liver diagnosis by using upper abdominal ultrasound echography (US)
• patients with T2D diagnosed according to ADA 2019 criteria and treated with metformin.

You may not qualify if:

• Pregnant and/or lactating women,
• excessive alcohol use (as defined by an average daily consumption of alcohol \> 30 g/day in men and \> 20 g/day women),
• patients with other causes of chronic liver disease as viral hepatitis, drug induced hepatitis, autoimmune hepatitis, patients suffering of chronic kidney disease, hyper/hypoparathyroidism,
• hypersensitivity to cholecalciferol,
• hypercalcemia,
• patients taking supplementation with vitamin D,
• calcium and medications affecting calcium/vitamin D metabolism (as: anticonvulsants, glucocorticoids, antacids).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

National hepatology and tropical medicine research institute

Cairo, 0000, Egypt

RECRUITING

Related Publications (1)

• Mohamed AA, Halim AA, Mohamed S, Mahmoud SM, Bahgat Eldemiry EM, Mohamed RS, Shaheen MM, Naguib GG, Muharram NM, Khalil MG, Saed S, Ibrahim R, Salah Seif A, Kamal N, Nasraldin K, Abdelrahman AE, El Borolossy R. The effect of high oral loading dose of cholecalciferol in non-alcoholic fatty liver disease patients. A randomized placebo controlled trial. Front Pharmacol. 2023 Mar 14;14:1149967. doi: 10.3389/fphar.2023.1149967. eCollection 2023.

  PMID: 36998617 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Radwa El Borolossy

  Faculty of pharmacy Ain Shams university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radwa El Borolossy, phd

CONTACT

01227052880; radwa.maher14@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study medications were given to the patients by an unblinded pharmacist to ensure the right treatment assignment, however this pharmacist was not included in the outcome assessment. All patients were diagnosed with NAFLD depending on abdominal ultrasonography performed by a radiologist where the liver brightness and liver parenchyma with diffuse echogenicity in confirm the diagnosis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of clinical pharmacy

Model Details: Group 1: patients received the standard conventional therapy in addition to placebo for 4 months. Group 2: patients received the standard conventional therapy in addition to a single oral dose of cholecalciferol 300,000 IU followed by oral cholecalciferol 800 IU daily for 4 months.

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 14, 2022
• Study Start: October 31, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 5, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)