Comparison of the efficacy of standard therapy with and without Vitamin D supplementation in patients of liver cirrhosis

To compare of the effectiveness of standard therapy with and without vitamin D supplementation in patients of Liver Cirrhosis.

Randomized controlled trial

OPD of Gastroenterology department, Mayo hospital Lahore. Participants were blinded by using identical ampules, non-revealing labeling and method of injection.

The study will include seventy-two male and female cirrhotic patients aged 30 to 60 years who will provide informed consent and will be receiving standard therapy. Patients with metastatic liver tumors, those unable to understand local languages, non-cooperative individuals, and critically ill cases — including those admitted to the ICU, on mechanical ventilation, in a coma, or with a Glasgow Coma Scale (GCS) score below 10 — will be excluded from the study. Additionally, patients who have received vitamin D treatment within the two months prior to recruitment will also be excluded.

Patients will be randomly supplemented with monthly single intramuscular dose of 200,000 IU cholecalciferol /vitamin D3 for 6 months (Vitamin D Group), and the second arm will receive a monthly single intramuscular dose of the placebo (ampule containing 1ml of normal saline 0.9%, that will be obtained from our colleagues in pharmacology department, for 6 months (Placebo Group)

The Chronic Liver Disease Questionnaire (CLDQ) will be used to measure changes in quality of life. The raw scores of the participants will be transformed into scale scores, and for all scales, higher scores will indicate better functioning or QOL.

1. Method of randomization: Simple randomization. 2. Unit of randomization: Individual patient. 3. Randomization strata in stratified randomization: Not applicable (no stratification used). 4. Tools used in randomization: Computer-generated random numbers and sealed opaque envelopes. 5. How the random sequence was built: Using a computer software to generate a random sequence. 6. Whether or not allocation concealment was carried out: Yes, through sealed, sequentially numbered opaque envelopes.

To ensure effective blinding, both the treatment group (receiving 200,000 IU of Vitamin D intramuscularly) and the placebo group (receiving 1 mL of normal saline intramuscularly) will be administered injections from ampoules that are identical in appearance, volume, and packaging. These ampoules will be coded with non-identifiable labels, such as Group A or B, and only the pharmacist or an independent third party, uninvolved in patient care or outcome assessment, will have access to the allocation code. Injections will be delivered using the same needle and syringe type, into the same anatomical site, and with standardized technique to prevent any perceptible differences in administration that might unblind participants. Although the administering staff will be aware of the contents in this single-blinded design, they will be trained to avoid any verbal or non-verbal cues that could influence the patients’ perceptions. All post-injection monitoring will be conducted uniformly without disclosing any information that could hint at group allocation.

Deidentified Individual Participant Data (IPD): Includes demographic data (age, sex, socioeconomic status), baseline clinical data (stage of cirrhosis, CLDQ scores), and follow-up outcome data (monthly CLDQ scores for 6 months). Analytic Code: Statistical analysis scripts used to compare outcomes, likely in SPSS or Excel. Study Protocol: Full protocol including objectives, methodology, inclusion/exclusion criteria, interventions, and outcome measures. Consent Form: Template of the informed consent document used in local languages. Data Dictionary: Variable definitions, coding instructions, units, and value ranges. Clinical Study Report (CSR): A structured report summarizing methodology, participant flow, statistical analysis, and results.

All data and documents will become available within 6 months after publication of the main study results in a peer-reviewed journal. They will remain available for a minimum of 5 years after the date of publication. Extensions may be granted upon request, subject to ethical approval and institutional guidelines.

Data and supporting documents will be shared with qualified researchers, healthcare professionals, and academics affiliated with recognized institutions, including universities, hospitals, and nonprofit research organizations. Access for commercial entities (e.g., pharma/biotech companies) may also be considered on a case-by-case basis, provided the intended use is ethically justified and approved by the principal investigator and institutional ethics committee. All requestors will be required to submit a data use agreement, outlining terms for privacy, data security, and non-commercial use unless explicitly approved.

Access to deidentified IPD and supporting documents will be granted for scientific research purposes only, such as: Secondary analysis to verify study results Meta-analyses or systematic reviews Methodological research or development of new analysis tools Academic research or graduate thesis work Requests must include a brief proposal outlining the research objective, intended use, methodology, and institutional affiliation. All requests will be reviewed by the Principal Investigator (PI) in consultation with the Institutional Ethics Committee. Approval will be based on the scientific merit, ethical soundness, and alignment with patient confidentiality protections.

All data and related documents can be requested from: Contact Person: Dr. Muhammad Umer Sheikh Institution: Department of Gastroenterology, Mayo Hospital, Lahore, Pakistan Email: dr.usheikh@gmail.com The data will be shared electronically through secure channels such as institutional file-sharing platforms or password-protected email attachments.

Initial Contact: Interested researchers should email a formal request to the Principal Investigator with: A brief research proposal Intended use of the data Institutional affiliation Ethical approval or justification (if available) Review Process: The request will be reviewed within 2–4 weeks by the Principal Investigator in collaboration with the institutional ethics committee. Data Use Agreement: If approved, the requester must sign a Data Use Agreement (DUA) that outlines confidentiality, non-commercial use, and data protection obligations. Data Sharing: Once the DUA is signed, data/documents will be sent electronically within 7–10 working days.