Article (Scientific journals)
NASAFYTOL® supplementation in adults hospitalized with COVID-19 infection: results from an exploratory open-label randomized controlled trial
Gérain, Jean; Uebelhoer, Melanie; Costes, Bérénice et al.
2023In Frontiers in Nutrition, 10
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Keywords :
Nutrition and Dietetics; Endocrinology, Diabetes and Metabolism; Food Science
Abstract :
[en] ObjectivesThe effect and safety of Nasafytol®, a food supplement combining curcumin, quercetin, and Vitamin D, on hospitalized COVID-19-positive patients as support to standard of care were to be assessed.MethodsThis exploratory, open-label, randomized, controlled trial was carried out among hospitalized adults with COVID-19 infection. Participants were randomly assigned to receive Nasafytol® or Fultium® control. The improvement of the clinical condition and occurrence of (serious) adverse events were evaluated. The study was registered on <jats:ext-link>clincaltrials.gov</jats:ext-link> with the identifier NCT04844658.ResultsTwenty-five patients received Nasafytol®, and 24 received Fultium®. Demographic characteristics were well balanced between the groups. On day 14 (or at hospital leave if &lt; 14 days), no difference was observed between groups regarding their clinical condition, fever, or the need of oxygen therapy. At day 7, however, 19 participants had been discharged from the hospital in the Nasafytol® arm compared to 10 participants in the Fultium® arm. No participants were transferred to the ICU or died in the Nasafytol® arm, vs. 4 transfers and 1 death in the Fultium® arm. The clinical condition of participants in the Nasafytol® arm had improved, as evidenced by a decrease in the COVID-19 WHO score. Interestingly, five SAEs occurred with Fultium®, while no SAE was observed with Nasafytol®.ConclusionSupplementation with Nasafytol®, in addition to standard-of-care treatment, led to a faster discharge from the hospital, improved clinical conditions of participants, and a reduced risk of serious outcomes, including transfer to the intensive care unit or death, in patients hospitalized with COVID-19.
Disciplines :
Human health sciences: Multidisciplinary, general & others
Author, co-author :
Gérain, Jean;  CHIREC Hospital Group, Brussels > Department of internal Medicine
Uebelhoer, Melanie;  Artialis SA
Costes, Bérénice;  Artialis SA
Herman, Julie;  Artialis SA
Pietri, Sandra;  Artialis SA
Donneau, Anne-Françoise  ;  Université de Liège - ULiège > Département des sciences de la santé publique
Monseur, Justine ;  Université de Liège - ULiège > Département des sciences de la santé publique > Biostatistique
Henrotin, Yves  ;  Université de Liège - ULiège > Département des sciences de la motricité > Pathologie générale et physiopathologie - Techniques particulières de kinésithérapie ; Artialis SA
Language :
English
Title :
NASAFYTOL® supplementation in adults hospitalized with COVID-19 infection: results from an exploratory open-label randomized controlled trial
Publication date :
22 June 2023
Journal title :
Frontiers in Nutrition
eISSN :
2296-861X
Publisher :
Frontiers Media SA
Volume :
10
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 31 July 2023

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