NCT02691533

To Study the Immunomodulating Effects and Safety Profile of ω3 and ω6 PUFA Containing Intravenous Lipid Emulsion in Patients With Acute on Chronic Liver Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Study population: Patients admitted or seen in OPD (Out Patient Department), Department of Hepatology. Study design- Prospective Randomized Controlled Trial. Study period-January 2016 to May 2017 Intervention- Subjects will be randomized into 3 groups Group A subjects will receive ω3 PUFA (Polyunsaturated Fatty Acids) (10% Omegavan 100 ml). Group B- will receive ω6 PUFA (Polyunsaturated Fatty Acids) (10% Intralipid 100 ml). Group C -Placebo group Monitoring and assessment- :- The following tests will be done in these patients:- 1. Complete clinical examination. 2. Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels 3. BUN (Blood Urea Nitrogen) 4. Serum free fatty acid levels 5. Lipid profile. 6. Arterial ammonia 7. Arterial lactate 8. Blood sugar and serum insulin levels

Conditions

• Chronic Liver Failure

Interventions

Type	Name	Description
DRUG	ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml)
DRUG	ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)
DRUG	No Lipid Emulsion/Placebo

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2016-02-25
• Last updated: 2018-09-05

Locations

1 site across 1 country: India