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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.
Arabi, Seyyed Mostafa; Hadi, Saeid; Gholambareshi, Parisa; Bahrami, Leila Sadat; Hazrati, Ebrahim; Mirghazanfari, Sayid Mahdi; Sahebkar, Amirhossein; Hadi, Vahid.
Affiliation
  • Arabi SM; Department of Biochemistry and Nutrition, Faculty of Medicine, AJA University of Medical Sciences, Tehran, Iran.
  • Hadi S; Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran.
  • Gholambareshi P; Department of Health, School of Medicine, AJA University of Medical Sciences, Tehran, Iran.
  • Bahrami LS; Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
  • Hazrati E; Noncommunicable Diseases Research Center, Neyshabur University of Medical Sciences, Neyshabur, Iran.
  • Mirghazanfari SM; Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
  • Sahebkar A; Trauma Research Center, AJA University of Medical Sciences, Tehran, Iran.
  • Hadi V; Department of Physiology and Iranian Medicine, School of Medicine, AJA University of Medical Sciences, Iran.
Contemp Clin Trials Commun ; 32: 101082, 2023 Apr.
Article in En | MEDLINE | ID: mdl-36742110
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.
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Clinical_trials / Guideline Language: En Journal: Contemp Clin Trials Commun Year: 2023 Document type: Article Affiliation country: Country of publication:

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Clinical_trials / Guideline Language: En Journal: Contemp Clin Trials Commun Year: 2023 Document type: Article Affiliation country: Country of publication: