NCT03732586

Effect of Omega 5 Fatty Acid as an Adyuvant Treatment to Prednisone in Patients With Severe Alcoholic Hepatitis

Completed NA Last updated 23 May 2023

What this trial tests

NA trial testing Omega 5 fatty acid supplement in Alcoholic Hepatitis in 40 participants. Completed in 22 May 2023.

Timeline

30 September 2018

Primary endpoint
1 January 2023

22 May 2023

Quick facts

Lead sponsor	Hospital General Dr. Manuel Gea González
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	30 September 2018
Primary completion	1 January 2023
Estimated completion	22 May 2023
Sites	2 locations across Mexico

Drugs / interventions tested

• Omega 5 fatty acid supplement
• PLACEBO

Conditions studied

• Alcoholic Hepatitis — all drugs for Alcoholic Hepatitis →

Sponsor

Hospital General Dr. Manuel Gea González

Who can join

Adults 18 to 65, any sex, with Alcoholic Hepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In Mexico, alcoholic liver disease is the fourth cause of mortality (INEGI). Patients with severe alcoholic hepatitis have a high mortality at 28 days and 6 months, patients receiving standard therapy with prednisone that are non responders (Lille\> 0.45) have a survival of 53.3 ± 5.1 % to 28 days. At present, there is not a completely effective treatment for non responders patients, with a high mortality, so it is necessary to look for other therapeutic strategies.

The omega-5 fatty acid (punicic acid) has been considered a powerful antioxidant, it is an agonist of PPAR gamma, has been shown to reduce lipid peroxidation, and restore levels of antioxidant enzymes such as superoxide dismutase (SOD), catalase and glutathione peroxidase. It has also been shown to inhibit the expression of proinflammatory cytokines (such as IL6, IL8, IL23, IL12 and TNFalpha) through PPAR and modulation delta.

The objective of this study is to evaluate the effect of Omega 5 fatty acid on inflammatory markers and antioxidant-oxidant balance markers in patients with severe alcoholic hepatitis treated with prednisone. HYPOTHESIS. Omega 5 fatty acid being a PPARgamma agonist reduces lipid peroxidation and protein damage, restoring reduced glutathione levels, as well as decreasing proinflammatory cytokines, in patients with Severe Alcoholic Hepatitis treated with prednisone and supplementation with fatty acid Omega 5.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The knowns and unknowns of treatment for alcoholic hepatitis.
   Sehrawat TS, Liu M, Shah VH. · · 2020 · cited 76× · PMID 32277902 · DOI 10.1016/s2468-1253(19)30326-7
2. Epidemiological Realities of Alcoholic Liver Disease: Global Burden, Research Trends, and Therapeutic Promise.
   Xiao J, Wang F, Wong NK, Lv Y, et al · · 2020 · cited 28× · PMID 32690129 · DOI 10.3727/105221620x15952664091823
3. Current Management and Future Treatment of Alcoholic Hepatitis.
   Mitchell MC, Kerr T, Herlong HF. · · 2020 · cited 12× · PMID 34035720
4. Therapeutic Pipeline in Alcohol-Associated Liver Disease.
   Thakral N, Deutsch-Link S, Singal AK. · · 2023 · cited 8× · PMID 36572032 · DOI 10.1055/s-0042-1759614
5. Therapeutic targets in alcohol-associated liver disease: progress and challenges.
   Adekunle AD, Adejumo A, Singal AK. · · 2023 · cited 6× · PMID 37187673 · DOI 10.1177/17562848231170946
6. The future of therapy for alcoholic hepatitis - Beyond corticosteroids.
   Vergis N, Atkinson SR, Thursz MR. · · 2019 · cited 5× · PMID 30791978 · DOI 10.1016/j.jhep.2019.01.016
7. Prospective clinical trials and novel therapies in the medical management of severe alcohol-associated hepatitis.
   Pimienta M, Tien C, Terrault NA. · · 2022 · cited 4× · PMID 36523864 · DOI 10.1002/cld.1265
8. Current Clinical Trials for Alcohol-Associated Hepatitis.
   Rady ED, Anouti A, Mitchell MC, Cotter TG. · · 2026 · cited 3× · PMID 40254132 · DOI 10.1016/j.ajpath.2025.03.009