NCT02923804

Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients

A Randomized, Double-Blind, Placebo-Controlled Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients When Added to Standard of Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Pronova BioPharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized, placebo-controlled, double-blind trial to determine the effect of high concentrate omega-3 capsules on the omega-3 status of patients with non-alcoholic fatty liver.

Detailed description

Subjects with non-alcoholic fatty liver (simple steatosis) confirmed within the last year by ultrasound or other imaging modality will be recruited to the study. Subjects will be randomized to a treatment arm of high concentrate capsules or placebo for a 6 month treatment period.Omega-3 content of red blood cells (omega-3 index) will be measured for primary endpoint assessment. Quantitative MRI will be performed to determine the effect on liver fat content.

Conditions

• Non Alcoholic Fatty Liver

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3	3x 1g capsules taken daily for 6 months
DIETARY_SUPPLEMENT	Olive oil	3x 1g capsules taken daily for 6 months

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-10-05
• Last updated: 2018-04-04

Locations

7 sites across 1 country: United States