NCT06131177

Nutritional Interventions in Patients With Alcohol-associated Hepatitis

Comparing Nutritional Interventions in Patients With Alcohol-associated Hepatitis: a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Western University, Canada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Alcohol-associated hepatitis (AH) is a life-threatening condition with high 90-days mortality (up to 40%) and limited treatment options. Previous studies have shown that decreased nutritional intake (less than 21 kcal/kg/day) is associated to a higher mortality compared to patients with a higher caloric intake. Additionally, it has been suggested that subjects with severe AH, should receive a high-protein diet, however, no specific trials have been carried out to address these questions. Thus, the investigators aim to compare nutritional interventions through a randomized controlled trial to assess if a strategy of peripheral parental nutrition (PPN) plus oral nutritional supplementation (ONS) improves outcomes in patients with severe AH. The investigators will compare standard oral intake, enhanced oral intake with IV fluid supplementation, and PPN plus ONS in patients admitted to hospital with severe AH. These results potentially will help guide practitioners on caloric benchmarks targets for patients with severe AH. This study will also assess specific risks and benefits of different nutritional interventions.

Conditions

• Alcoholic Hepatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutritional supplement	Protein supplement

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-11-14
• Last updated: 2024-05-29