Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202509709405673 Date of Registration: 10/09/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Vitamin D and Fatty Liver Disease: A Clinical Trial in Egypt
Official scientific title Effect of Vitamin D Supplementation on Steatosis in Patients with Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Metabolic dysfunction-associated steatotic liver disease (MASLD) is one of the most common chronic liver disorders worldwide, closely linked to obesity, diabetes, and other metabolic risk factors. In parallel, vitamin D deficiency is highly prevalent and has been associated with insulin resistance, inflammation, and liver disease progression. Growing evidence suggests a possible interaction between vitamin D status and MASLD severity, but the relationship remains controversial, highlighting the need for further clinical studies..This study was conducted to evaluate the effect of vitamin D supplementation on liver steatosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Forty patients were enrolled and randomly assigned into two groups: 20 patients received vitamin D supplementation, while 20 patients did not receive any intervention. The primary outcome was the improvement in hepatic steatosis, assessed by fibroscan. Secondary outcomes included changes in liver enzymes , lipid profile , CBC and metabolic parameters.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Infections and Infestations
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 17/08/2022
Actual trial start date 01/08/2023
Anticipated date of last follow up 01/08/2025
Actual Last follow-up date 01/07/2025
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
HV01 2021 the commision on the ethics of scientific research , faculty of pharmacy, minia univeristy, Egypt.
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vitamin D intervention 200 000 iu / 1 ml IM injection every 14 days 3 months “We conducted a randomized controlled study in which patients with MASLD and vitamin D deficiency received vitamin D supplementation. Clinical, biochemical, and radiological parameters were assessed at baseline and after the intervention period to evaluate the effect of vitamin D replacement on disease outcomes.” 20
Control Group controll group 0.9% NaCl sterile, pyrogen-free every 2 weeks for 3 months “We conducted a randomized controlled study in which the control group receive placebo.Clinical, biochemical, and radiological parameters were assessed at baseline and after the intervention period to evaluate the disease outcomes.” 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion: Adults with metabolic dysfunction-associated steatotic liver disease, aged 18–60 years Patients with other chronic liver diseases, significant alcohol consumption, or contraindications to vitamin D therapy. Adult: 19 Year-44 Year 19 Year(s) 44 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/05/2022 the commission on the ethics of scientific research faculty of pharmcy mina univeristy Egypt
Ethics Committee Address
Street address City Postal code Country
Agricultural Road, beside Minia University, Minia, Egypt Minia 61512 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improvement in hepatic steatosis assessed by fibroscan and lab analysis after 3 months. 3 months after intervention
Secondary Outcome Changes in ALT, AST, and metabolic profile. 3 months after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Liver and Digestive System Hospital MINA UNIVERISTY Agricultural Road, beside Minia University, Minia, Egypt MINIA 61512 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ali Ahmed Ali Ismeal minia minia 61512 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor minia univeristy Damaris, Second Al Minya, Minya Governorate 2431436 minia 61512 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ali Ahmed ali.esmael@mu.edu.eg +201032132661 mallawi
City Postal code Country Position/Affiliation
MINIA 61512 Egypt teaching assistant
Role Name Email Phone Street address
Scientific Enquiries eman sadek ali.esmael@mu.edu.eg 01032132661 minia
City Postal code Country Position/Affiliation
minia 61111 Egypt Lecturer of Clinical Pharmacy Faculty of Pharmacy
Role Name Email Phone Street address
Public Enquiries wael soliman ali.esmael@mu.edu.eg 01032132661 minia
City Postal code Country Position/Affiliation
minia 61111 Egypt lecturer of gastroenterology hepatology and infectious Department Faculty of Medicine Minia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (IPD) underlying the results of this study will be available from the corresponding author upon reasonable request after publication. Informed Consent Form,Study Protocol IPD will be available beginning 6 months and ending 3 years following publication of the study results. Researchers who provide a methodologically sound proposal will be able to access the IPD. Proposals should be directed to the corresponding author.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.minia.edu.eg/pharmacy No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 03/09/2025 to be suitable for reviewer This study was conducted to evaluate the effect of vitamin D supplementation on liver steatosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Forty patients were enrolled and randomly assigned into two groups: 20 patients received vitamin D supplementation, while 20 patients did not receive any intervention. The primary outcome was the improvement in hepatic steatosis, assessed by fibroscan. Secondary outcomes included changes in liver enzymes , lipid profile , CBC and metabolic parameters. Metabolic dysfunction-associated steatotic liver disease (MASLD) is one of the most common chronic liver disorders worldwide, closely linked to obesity, diabetes, and other metabolic risk factors. In parallel, vitamin D deficiency is highly prevalent and has been associated with insulin resistance, inflammation, and liver disease progression. Growing evidence suggests a possible interaction between vitamin D status and MASLD severity, but the relationship remains controversial, highlighting the need for further clinical studies..This study was conducted to evaluate the effect of vitamin D supplementation on liver steatosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Forty patients were enrolled and randomly assigned into two groups: 20 patients received vitamin D supplementation, while 20 patients did not receive any intervention. The primary outcome was the improvement in hepatic steatosis, assessed by fibroscan. Secondary outcomes included changes in liver enzymes , lipid profile , CBC and metabolic parameters.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 03/09/2025 to be suitable for reviewer This study was conducted to evaluate the effect of vitamin D supplementation on liver steatosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Forty patients were enrolled and randomly assigned into two groups: 20 patients received vitamin D supplementation, while 20 patients did not receive any intervention. The primary outcome was the improvement in hepatic steatosis, assessed by fibroscan. Secondary outcomes included changes in liver enzymes , lipid profile , CBC and metabolic parameters. Metabolic dysfunction-associated steatotic liver disease (MASLD) is one of the most common chronic liver disorders worldwide, closely linked to obesity, diabetes, and other metabolic risk factors. In parallel, vitamin D deficiency is highly prevalent and has been associated with insulin resistance, inflammation, and liver disease progression. Growing evidence suggests a possible interaction between vitamin D status and MASLD severity, but the relationship remains controversial, highlighting the need for further clinical studies..This study was conducted to evaluate the effect of vitamin D supplementation on liver steatosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Forty patients were enrolled and randomly assigned into two groups: 20 patients received vitamin D supplementation, while 20 patients did not receive any intervention. The primary outcome was the improvement in hepatic steatosis, assessed by fibroscan. Secondary outcomes included changes in liver enzymes , lipid profile , CBC and metabolic parameters.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 03/09/2025 to be suitable for reviewer Experimental Group, vitamin D intervention , 200 000 iu / 1 ml IM injection every 14 days , 3 months , “We conducted a randomized controlled study in which patients with MASLD and vitamin D deficiency received vitamin D supplementation. Clinical, biochemical, and radiological parameters were assessed at baseline and after the intervention period to evaluate the effect of vitamin D replacement on disease outcomes.”, 20,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 03/09/2025 to be suitable for reviewer Control Group, controll group , 0.9% NaCl sterile, pyrogen-free, every 2 weeks for 3 months, “We conducted a randomized controlled study in which the control group receive placebo.Clinical, biochemical, and radiological parameters were assessed at baseline and after the intervention period to evaluate the disease outcomes.”, 20, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 03/09/2025 the required mail TRUE, the commission on the ethics of scientific research faculty of pharmcy mina univeristy Egypt , Agricultural Road, beside Minia University, Minia, Egypt, Minia , 61512, Egypt, , 12 May 2022, +20862347759, ali.esmael@mu.edu.eg, 37048_33225_4737.pdf TRUE, the commission on the ethics of scientific research faculty of pharmcy mina univeristy Egypt , Agricultural Road, beside Minia University, Minia, Egypt, Minia , 61512, Egypt, , 12 May 2022, +20862347759, MPEC@pharm.s-mu.edu.eg, 37048_33225_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 03/09/2025 the actual name self funding , minia , minia , 61512, Egypt, Self Funded, Ali Ahmed Ali Ismeal , minia , minia , 61512, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Minimum age 03/09/2025 to be suitable 18 Year(s) 19 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Maximum age 03/09/2025 to be suitable 60 Year(s) 44 Year(s)