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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202511471802051 Date of Registration: 26/11/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Multifaceted Assessment of Patients with Wilson’s Disease in a Low-Resource Setting in Upper Egypt: Service Integration, Psychosocial Burden, Dietary Practices, and the Geo-Spatial Disease Map
Official scientific title Multifaceted Assessment of Patients with Wilson’s Disease in a Low-Resource Setting in Upper Egypt: Service Integration, Psychosocial Burden, Dietary Practices, and the Geo-Spatial Disease Map
Brief summary describing the background and objectives of the trial Wilson’s disease (WD) is a rare autosomal recessive disorder of copper metabolism, caused by mutations in the *ATP7B* gene, leading to impaired copper metabolism and toxic accumulation in many organs including the liver, brain, and cornea with subsequent hepatic and neuropsychiatric manifestations . Early diagnosis and adherence to lifelong dietary restrictions and chelation therapy are critical to prevent irreversible damage . WD is one of the few inborn metabolic diseases that can be successfully treated, and its complications can be prevented especially if diagnosed early and managed properly. However, in low-resource settings, patients often face barriers such as delayed diagnosis, poor awareness, limited access to care, and financial constraints. This study aims to: Assess KAB-pB and perceived barriers among WD patients.Map geographic distribution and access to care.Explore dietary practices and affordability.Understand psychosocial burden and coping strategies.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/11/2025
Actual trial start date
Anticipated date of last follow up 01/11/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Single Group Non-randomised Allocation Sequence/Code was not concealed Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dietary Practices Survey once once This tool will explore: • Food frequency of copper-rich and copper-safe items, tailored to local Egyptian diets. • Beliefs about the health impact of specific foods. • Affordability scale: A 3-point scale assessing economic feasibility of dietary recommendations 80
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients aged 13 years and older with a confirmed diagnosis of Wilson’s Disease based on clinical, biochemical, radiological, slit-lap examination and genetic criteria, who are on regular follow up at Assiut Liver Center, and the Specialized Wilson’s Disease Clinic. 2. Patients who are clinically stable and able to participate in interviews or complete surveys. 1. Patients experiencing acute hepatic or neurological decompensation at the time of recruitment. 2. Individuals with cognitive impairments that preclude informed consent or meaningful participation. 3. Patients or caregivers who refuse to provide consent. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 13 Year(s) 65 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
No 30/10/2025 Institutional Review Board of Faculty of Medicine Assiut university
Ethics Committee Address
Street address City Postal code Country
Assiut university Asyut 71515 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Dietary Adherence Index: A composite score based on the Dietary Practices Survey, reflecting the level of adherence to copper-restricted diets and the affordability challenges faced. during observation 0 hour
Secondary Outcome Geographic Access Metrics: Quantitative data on distance to care (km), travel time (hours), and transportation cost (EGP) per visit, visualized on a geospatial map during observation 0 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut university hospitals Assiut university Asyut 71515 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Abdelrahman Mostafa Ahmed Hassan Assiut university Asyut 71515 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Abdelrahman Mostafa Ahmed Hassan Assiut university Asyut 71515 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Abdelrahman Mostafa Ahmed Hassan abdelrahmanmustafa286@gmail.com +201023870217 Assiut university
City Postal code Country Position/Affiliation
Asyut 71515 Egypt residant doctor at Tropical Medicine and Gastroenterology Assiut University
Role Name Email Phone Street address
Principal Investigator Ahmed Helmy Salem ahsalem@aun.edu.eg +201032059496 Assiut university
City Postal code Country Position/Affiliation
Asyut 71515 Egypt professor at Tropical Medicine and Gastroenterology Assiut University
Role Name Email Phone Street address
Scientific Enquiries Hani Abdelawaad Ismail Sayed HaniAbdelawaad@gmail.com +201022002006 Assiut university
City Postal code Country Position/Affiliation
Asyut 71515 Egypt lecturer at Medicine and Gastroenterology Luxor 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 made available to researchers upon reasonable request from the corresponding author after the publication of results, for a period of one year. The shared data will include anonymized variables relevant to the primary and secondary outcomes Informed Consent Form,Study Protocol 12 months after publication of results data will be available upon a reasonable request from the corresponding author.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Reporting IPD description 18/11/2025 IDP description The individual participant data (IPD) collected during this study will not be shared with other researchers or organizations because they contain potentially sensitive information and participants did not provide consent for data sharing. However, summary results of the study will be made publicly available within 12 months of study completion, in accordance with WHO requiremens De-identified individual participant data (IPD) underlying the results of this study will be made available to researchers upon reasonable request from the corresponding author after the publication of results, for a period of one year. The shared data will include anonymized variables relevant to the primary and secondary outcomes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 18/11/2025 IPD-Sharing Time Frame * There is no plan to share individual participant data (IPD) at any time, as the dataset contains sensitive information and participants did not provide consent for data sharing 12 months after publication of results
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 18/11/2025 Access Criteria * Access to individual participant data will not be granted because the data contain sensitive information and participants did not consent to data sharing data will be available upon a reasonable request from the corresponding author.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 18/11/2025 shared docoment Informed Consent Form Study Protocol, Informed Consent Form