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Randomized Clinical Trial
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World J Methodol. Jun 20, 2026; 16(2): 112692
Published online Jun 20, 2026. doi: 10.5662/wjm.v16.i2.112692
Open-label randomized controlled study of salt-restricted vs salt-unrestricted diet in patients with cirrhosis with hyponatremia
Sudheer Marrapu, Ramesh Kumar, Divendu Bhushan, Sudhir Kumar, Abhishek Kumar, Rajeev N Priyadarshi, Utpal Anand
Sudheer Marrapu, Ramesh Kumar, Sudhir Kumar, Abhishek Kumar, Department of Gastroenterology, All India Institute of Medical Sciences, Patna 801507, Bihar, India
Divendu Bhushan, Department of Emergency Medicine, All India Institute of Medical Sciences, Patna 801507, Bihar, India
Rajeev N Priyadarshi, Department of Radiodiagnosis, All India Institute of Medical Sciences, Patna 801507, Bihar, India
Utpal Anand, Department of Surgical Gastroenterology, All India Institute of Medical Sciences, Patna 801507, Bihar, India
Author contributions: Marrapu S and Kumar R designed the study, analyzed the data, and drafted the manuscript; Bhushan D, Kumar S, and Kumar A collected the data and contributed to the writing of the manuscript; Priyadarshi RN and Anand U assisted with the data collection and reviewed the manuscript; All authors approved the final version.
Institutional review board statement: The study protocol was approved by the Institutional Ethics Committee (No. AIIMS/Pat/IEC/PGT/Jan23-06) and conducted in accordance with the Declaration of Helsinki.
Informed consent statement: Informed consent for the study and publication was obtained from each patient included in this study.
Conflict-of-interest statement: The authors have no conflicts of interest to declare.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: Supporting data are available in a standard proforma and Microsoft Excel spreadsheet, and will be provided upon receipt of a valid and appropriate request.
Corresponding author: Ramesh Kumar, MD, Professor, DM, Head, Department of Gastroenterology, All India Institute of Medical Sciences, Phulwari Sharif, Patna 801507, India. docrameshkr@gmail.com
Received: August 4, 2025
Revised: August 22, 2025
Accepted: January 9, 2026
Published online: June 20, 2026
Processing time: 263 Days and 18.4 Hours
Core Tip

Core Tip: This study highlights the potential harm of salt restriction in patients with cirrhosis with moderate to severe hyponatremia. Patients in the salt-restricted diet group (5 g/day) had significantly higher risk of acute kidney injury, poorer nutritional and hemodynamic profiles, and increased short-term mortality compared to those in the salt-unrestricted diet group (10 g/day). Importantly, no significant improvement in ascites control was observed with salt restriction. These results question the routine use of salt restriction in this subgroup and emphasize the need for a more tailored dietary approach to optimize renal function, nutrition, and survival outcomes in patients with hyponatremic cirrhosis.