Effect of vitamin D supplementation versus placebo on recovery delay among COVID-19 Tunisian patients: a randomized-controlled clinical trial

DOI record: { "DOI": "10.1186/s13063-023-07114-5", "ISSN": [ "1745-6215" ], "URL": "http://dx.doi.org/10.1186/s13063-023-07114-5", "abstract": "<jats:title>Abstract\n</jats:title><jats:sec>\n <jats:title>Introduction</jats:title>\n <jats:p>The present study aimed to determine the impact of vitamin D supplementation (VDs) on recovery delay among COVID-19 patients.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Methods</jats:title>\n <jats:p>We performed a randomized controlled clinical trial at the national COVID-19 containment center in Monastir (Tunisia), from May to August 2020. Simple randomization was done in a 1:1 allocation ratio. We included patients aged more than 18 years who had confirmed reverse transcription-polymerase chain reaction (RT-PCR) and who remained positive on the 14th day. The intervention group received VDs (200,000 IU/1 ml of cholecalciferol); the control group received a placebo treatment (physiological saline (1 ml)). We measured the recovery delay and the cycle threshold (Ct) values in RT-PCR for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The log-rank test and hazard ratios (HR) were calculated.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>A total of 117 patients were enrolled. The mean age was 42.7 years (SD 14). Males represented 55.6%. The median duration of viral RNA conversion was 37 days (95% confidence interval (CI): 29–45.50) in the intervention group and 28 days (95% CI: 23–39) in the placebo group (<jats:italic>p</jats:italic>=0.010). HR was 1.58 (95% CI: 1.09–2.29, <jats:italic>p</jats:italic>=0.015). Ct values revealed a stable trend over time in both groups.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Conclusion</jats:title>\n <jats:p>VDs was not associated with a shortened recovery delay when given to patients for whom the RT-PCR remained positive on the 14th day.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Trial registration\n</jats:title>\n <jats:p>This study was approved by the Human Subjects Protection Tunisia center (TN2020-NAT-INS-40) on April 28, 2020, and by ClinicalTrial.gov on May 12, 2021 with approval number ClinicalTrials.gov ID: <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://clinicaltrials.gov/ct2/show/NCT04883203\">NCT04883203</jats:ext-link>.</jats:p>\n </jats:sec>", "alternative-id": [ "7114" ], "article-number": "123", "assertion": [ { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Received", "name": "received", "order": 1, "value": "19 January 2022" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Accepted", "name": "accepted", "order": 2, "value": "23 January 2023" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "First Online", "name": "first_online", "order": 3, "value": "20 February 2023" }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "name": "Ethics", "order": 1 }, { "group": { "label": "Ethics approval and consent to participate", "name": "EthicsHeading" }, "name": "Ethics", "order": 2, "value": "This study was approved by the Human Subjects Protection Tunisia center (TN2020-NAT-INS-40) and by ClinicalTrial.gov with approval numberClinicalTrials.gov ID: NCT04883203. The research ethical considerations were respected including free, informed, written, clear and loyal consent, confidentiality, protection, and assistance" }, { "group": { "label": "Consent for publication", "name": "EthicsHeading" }, "name": "Ethics", "order": 3, "value": "Not applicable." }, { "group": { "label": "Competing interests", "name": "EthicsHeading" }, "name": "Ethics", "order": 4, "value": "The authors declare that they have no competing interests." } ], "author": [ { "ORCID": "http://orcid.org/0000-0002-9666-4914", "affiliation": [], "authenticated-orcid": false, "family": "Abroug", "given": "Hela", "sequence": "first" }, { "affiliation": [], "family": "Maatouk", "given": "Amani", "sequence": "additional" }, { "affiliation": [], "family": "Bennasrallah", "given": "Cyrine", "sequence": "additional" }, { "affiliation": [], "family": "Dhouib", "given": "Wafa", "sequence": "additional" }, { "affiliation": [], "family": "Ben Fredj", "given": "Manel", "sequence": "additional" }, { "affiliation": [], "family": "Zemni", "given": "Imen", "sequence": "additional" }, { "affiliation": [], "family": "Kacem", "given": "Meriem", "sequence": "additional" }, { "affiliation": [], "family": "Mhalla", "given": "Salma", "sequence": "additional" }, { "affiliation": [], "family": "Nouira", "given": "Sarra", "sequence": "additional" }, { "affiliation": [], "family": "Ben Belgacem", "given": "Manel", "sequence": "additional" }, { "affiliation": [], "family": "Nasri", "given": "Aymen", "sequence": "additional" }, { "affiliation": [], "family": "Klii", "given": "Rim", "sequence": "additional" }, { "affiliation": [], "family": "Loussaief", "given": "Chawki", "sequence": "additional" }, { "affiliation": [], "family": "Ben Alya", "given": "Nissaf", "sequence": "additional" }, { "affiliation": [], "family": "Bouanene", "given": "Ines", "sequence": "additional" }, { "affiliation": [], "family": "Belguith Sriha", "given": "Asma", "sequence": "additional" } ], "container-title": "Trials", "container-title-short": "Trials", "content-domain": { "crossmark-restriction": false, "domain": [ "link.springer.com" ] }, "created": { "date-parts": [ [ 2023, 2, 20 ] ], "date-time": "2023-02-20T12:03:23Z", "timestamp": 1676894603000 }, "deposited": { "date-parts": [ [ 2023, 2, 20 ] ], "date-time": "2023-02-20T12:09:07Z", "timestamp": 1676894947000 }, "indexed": { "date-parts": [ [ 2023, 2, 21 ] ], "date-time": "2023-02-21T05:36:51Z", "timestamp": 1676957811422 }, "is-referenced-by-count": 0, "issue": "1", "issued": { "date-parts": [ [ 2023, 2, 20 ] ] }, "journal-issue": { "issue": "1", "published-online": { "date-parts": [ [ 2023, 12 ] ] } }, "language": "en", "license": [ { "URL": "https://creativecommons.org/licenses/by/4.0", "content-version": "tdm", "delay-in-days": 0, "start": { "date-parts": [ [ 2023, 2, 20 ] ], "date-time": "2023-02-20T00:00:00Z", "timestamp": 1676851200000 } }, { "URL": "https://creativecommons.org/licenses/by/4.0", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2023, 2, 20 ] ], "date-time": "2023-02-20T00:00:00Z", "timestamp": 1676851200000 } } ], "link": [ { "URL": "https://link.springer.com/content/pdf/10.1186/s13063-023-07114-5.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://link.springer.com/article/10.1186/s13063-023-07114-5/fulltext.html", "content-type": "text/html", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://link.springer.com/content/pdf/10.1186/s13063-023-07114-5.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "297", "original-title": [], "prefix": "10.1186", "published": { "date-parts": [ [ 2023, 2, 20 ] ] }, "published-online": { "date-parts": [ [ 2023, 2, 20 ] ] }, "publisher": "Springer Science and Business Media LLC", "reference": [ { "author": "A Pan", "first-page": "1", "issue": "19", "journal-title": "China. 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