NASAFYTOL® supplementation in adults hospitalized with COVID-19 infection: results from an exploratory open-label randomized controlled trial
Jean Gérain, Melanie Uebelhoer, Bérénice Costes, Julie Herman, Sandra Pietri, Anne-Françoise Donneau, Justine Monseur, Yves Henrotin
Frontiers in Nutrition, doi:10.3389/fnut.2023.1137407
Objectives: The 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.
Methods: This 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 clincaltrials.gov with the identifier NCT04844658. Results: Twenty-five patients received Nasafytol ® , and 24 received Fultium ® . Demographic characteristics were well balanced between the groups. On day 14 (or at hospital leave if < 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 ® . Conclusion: Supplementation 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.
Ethics statement The studies involving human participants were reviewed and approved by Ethics Committee of the University Hospital of Brussels (Erasme-ULB) in Belgium (Comité d'Ethique Hospitalo-Facultaire Erasme-ULB) (protocol code B4062020000305 on January 15, 2021). The patients/participants provided their written informed consent to participate in this study.
Author contributions BC and YH: conceptualization. JG, BC, JH, and YH: methodology. A-FD and JM: statistical analysis. JG: investigation. MU and YH: writing-original draft preparation. JG, BC, JH, SP, A-FD, and JM: writing-review and editing. MU, BC, and JH: project administration. JG, MU, BC, JH, SP, A-FD, JM, and YH had full access to all the data in the study and had final responsibility for the decision to submit for publication. BC, JH, and YH accessed and verified the data. All authors contributed to the article and approved the submitted version.
Conflict of interest YH is the founder and president of Artialis SA, a spin-off company of the University of Liège. YH has also received consulting and speaker fees from Tilman SA, Nestlé, Laboratoire Expanscience, Heel,
Publisher's note All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed..
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'Intakes for Calcium and Vitamin DDietary Reference Intakes for Calcium '
'and Vitamin D',
'author': 'Ross',
'year': '2011'}],
'container-title': 'Frontiers in Nutrition',
'original-title': [],
'link': [ { 'URL': 'https://www.frontiersin.org/articles/10.3389/fnut.2023.1137407/full',
'content-type': 'unspecified',
'content-version': 'vor',
'intended-application': 'similarity-checking'}],
'deposited': { 'date-parts': [[2023, 6, 23]],
'date-time': '2023-06-23T16:46:27Z',
'timestamp': 1687538787000},
'score': 1,
'resource': {'primary': {'URL': 'https://www.frontiersin.org/articles/10.3389/fnut.2023.1137407/full'}},
'subtitle': [],
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'issued': {'date-parts': [[2023, 6, 22]]},
'references-count': 33,
'alternative-id': ['10.3389/fnut.2023.1137407'],
'URL': 'http://dx.doi.org/10.3389/fnut.2023.1137407',
'relation': {},
'ISSN': ['2296-861X'],
'subject': ['Nutrition and Dietetics', 'Endocrinology, Diabetes and Metabolism', 'Food Science'],
'container-title-short': 'Front. Nutr.',
'published': {'date-parts': [[2023, 6, 22]]}}