Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Feb 20;24(1):123.
doi: 10.1186/s13063-023-07114-5.

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

Hela Abroug  1   2   3 , Amani Maatouk  4 , Cyrine Bennasrallah  4 , Wafa Dhouib  4 , Manel Ben Fredj  4   5   6 , Imen Zemni  4   5   6 , Meriem Kacem  4   5 , Salma Mhalla  7 , Sarra Nouira  7 , Manel Ben Belgacem  8 , Aymen Nasri  8 , Rim Klii  9 , Chawki Loussaief  10 , Nissaf Ben Alya  11 , Ines Bouanene  4   5 , Asma Belguith Sriha  4   5   6
Affiliations
Randomized Controlled Trial

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

Hela Abroug et al. Trials. .

Abstract

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 .

Keywords: Adult; Convalescence; Infection; SARS-CoV-2; Tunisia; Vitamins.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study protocol flow diagram. Patients with a positive RT-PCR test at 14 days in the containment center were eligible to be included in the present study. The RT-PCR control test was weekly if it remained positive. The maximum period of staying in the center was 3 months. The phone follow-up was done at 1 year and asking about persistent COVID-19 symptoms and a possible second COVID-19 infection after the first episode. RT-PCR, reverse transcription-polymerase chain reaction
Fig. 2
Fig. 2
Patients flow diagram. One hundred thirty patients were eligible. A total of 117 patients were randomized into 2 groups: 57 patients (48.7%) in the vitamin D supplementation group and 60 (51.3%) in the control group. RT-PCR, reverse transcription-polymerase chain reaction
Fig. 3
Fig. 3
The recovery delays according to vitamin D supplementation (A) and hazard ratio (B). A The median duration of viral RNA conversion was 37 days (IQR: 29–45.50) in the intervention group and 28 days (IQR: 23–39) in the placebo group (p=0.010). B: HR was 1.58 (95% CI: 1.093–2.292, p=0.015). CI, confidence interval; HR, hazard ratio; RNA, ribonucleic acid; Vit D, vitamin D
Fig. 4
Fig. 4
Scatter plots and linear regression of the cycle threshold (Ct) value distribution over time in the placebo group A and in the vitamin D supplementation group B. A Placebo group: b= −0.024 (SE=0.029), r=−0.118, p=0.399). B VDs group b= 0.028 (SE=0.02), r=0.172, p=0.164. Ct values revealed a stable trend over time in both intervention groups. b, slope of linear regression; SE, standard error; VDs, vitamin D supplementation
See this image and copyright information in PMC

References

    1. Pan A, Liu L, Wang C, Guo H, Hao X, Wang Q, et al. Association of public health interventions with the epidemiology of the COVID-19 outbreak in Wuhan. China. JAMA. 2020;323(19):1–9. - PMC - PubMed
    1. Sadeghi Dousari A, TaatiMoghadam M, Satarzadeh N. COVID-19 (Coronavirus Disease 2019): A new coronavirus disease. Infect Drug Resist. 2020;12(13):2819–28. doi: 10.2147/IDR.S259279. - DOI - PMC - PubMed
    1. Kim H. Outbreak of novel coronavirus (COVID-19): What is the role of radiologists? Eur Radiol. 2020;18:1–2. - PMC - PubMed
    1. Brito DTM, Ribeiro LHC, Daltro CH da C, Silva R de B. The possible benefits of vitamin D in COVID-19. Nutr Burbank Los Angel Cty Calif. 2021;91:111356. doi: 10.1016/j.nut.2021.111356. - DOI - PMC - PubMed
    1. Grove A, Osokogu O, Al-Khudairy L, Mehrabian A, Zanganeh M, Brown A, et al. Association between vitamin D supplementation or serum vitamin D level and susceptibility to SARS-CoV-2 infection or COVID-19 including clinical course, morbidity and mortality outcomes? A systematic review. BMJ Open. 2021;11(5):e043737. doi: 10.1136/bmjopen-2020-043737. - DOI - PMC - PubMed

Publication types

Associated data