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- Effect of vitamin D supplementation versus placebo on recovery delay among COVID-19 Tunisian patients: a randomized-controlled clinical trial
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Effect of vitamin D supplementation versus placebo on recovery delay among COVID-19 Tunisian patients: a randomized-controlled clinical trial
Trials volume 24, Article number: 123 (2023)
Hela Abroug, Amani Maatouk, Cyrine Bennasrallah, Wafa Dhouib, Manel Ben Fredj, Imen Zemni, Meriem Kacem, Salma Mhalla, Sarra Nouira, Manel Ben Belgacem, Aymen Nasri, Rim Klii, Chawki Loussaief, Nissaf Ben Alya, Ines Bouanene & Asma Belguith Sriha
Introduction
The present study aimed to determine the impact of vitamin D supplementation (VDs) on recovery delay among COVID-19 patients.Methods
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.Results
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 (p=0.010). HR was 1.58 (95% CI: 1.09–2.29, p=0.015). Ct values revealed a stable trend over time in both groups.Conclusion
VDs was not associated with a shortened recovery delay when given to patients for whom the RT-PCR remained positive on the 14th day.Trial registration
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: NCT04883203.
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VitaminDWiki – COVID-19 treated by Vitamin D - studies, reports, videos
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