The effect of l-carnitine supplementation on mortality and clinical outcomes in ventilator-dependent critically ill patients with obesity and COVID-19: Protocol for a randomized double-blind placebo-controlled trial

Seyyed Mostafa Arabi; Saeid Hadi; Parisa Gholambareshi; Leila Sadat Bahrami; Ebrahim Hazrati; Sayid Mahdi Mirghazanfari; Amirhossein Sahebkar; Vahid Hadi

doi:10.1016/j.conctc.2023.101082

The effect of l-carnitine supplementation on mortality and clinical outcomes in ventilator-dependent critically ill patients with obesity and COVID-19: Protocol for a randomized double-blind placebo-controlled trial

Contemp Clin Trials Commun. 2023 Apr:32:101082. doi: 10.1016/j.conctc.2023.101082. Epub 2023 Jan 31.

Authors

Seyyed Mostafa Arabi^{1

2}, Saeid Hadi³, Parisa Gholambareshi⁴, Leila Sadat Bahrami^{2

4}, Ebrahim Hazrati⁵, Sayid Mahdi Mirghazanfari⁶, Amirhossein Sahebkar^{7

8}, Vahid Hadi¹

Affiliations

¹ Department of Biochemistry and Nutrition, Faculty of Medicine, AJA University of Medical Sciences, Tehran, Iran.
² Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran.
³ Department of Health, School of Medicine, AJA University of Medical Sciences, Tehran, Iran.
⁴ Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
⁵ Trauma Research Center, AJA University of Medical Sciences, Tehran, Iran.
⁶ Department of Physiology and Iranian Medicine, School of Medicine, AJA University of Medical Sciences, Iran.
⁷ Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
⁸ Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.

Abstract

Background: Coronavirus disease 2019 (COVID-19) still remains a pandemic accounting for at least 15% of intensive care unit (ICU) admissions. Recently, it has been observed that l-carnitine levels, which play an important role in fatty acid metabolism, have an inverse association with the severity of COVID-19 and its complications, hence a potential role for supplementing with this nutraceutical has been suggested. The current protocol describes a trial aiming to an evaluation of the effect of l-carnitine intervention on mortality and clinical outcomes in ICU-admitted patients with COVID-19.

Methods: This parallel-group, randomized, placebo-controlled, and double-blind clinical trial involves 50 participants and will be performed at the ICU of Artesh (AJA) Hospital, Mashhad, IRAN. Eligible participants will be randomized into two groups: 1) the intervention group will receive 1000 mg l-carnitine capsules 3 times a day, and 2) the placebo group will receive 1000 mg placebo capsules 3 times a day. Assessments will be performed at baseline, 7 and 28 days after study initiation. The primary outcome includes changes in serum levels of C-reactive protein (CRP). Secondary outcomes include the length of stay in the ICU, ICU mortality, hospital mortality, 28-day mortality, duration of mechanical ventilation (MV), and the neutrophil-lymphocyte ratio (NLR).

Conclusion: Based on previous evidence, l-carnitine may reduce inflammation and oxidation stress and improve respiratory function. However, the effects of l-carnitine on ventilator-dependent COVID-19 critically ill patients have not been assessed yet, justifying the necessity to conduct a clinical study in this field. c.

Keywords: COVID-19; Critically ill; ICU; Mortality; l-carnitine.