Trial Saudi Clinical Trial Registry (SCTR): 20061006
Publication Sabico S, Nutrients, 2021 (published paper)
Dates: 2020-07-29 to 2020-09-22
Funding: Mixed (King Saud University, Riyadh; Vitamin D supplements provided by Synergy Pharma (Dubai, UAE))
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / Saudi Arabia Follow-up duration (days): * | |
| Inclusion criteria | Male and female; aged 20–75 years old; RT-PCR confirmed SARS-CoV-2 positive diagnosis (not more than 3 days prior to inclusion); presenting with mild to moderate symptoms (As per the definition of the Saudi Ministry of Health (MoH)); protocol for RT-PCR-confirmed COVID-19 cases, a mild-moderate category meant that the patient required no O2 on presentation, had no evidence of pneumonia but had clinical symptoms (e.g., fever), the management of which was supportive care); consented voluntarily (written and verbal;criteria for hospital admission required a confirmed/suspected COVID-19 patient who was symptomatic with evidence of pneumonia; above 65 years; ARDS; the presence of comorbidities an |
| Exclusion criteria | Severe COVID-19 cases (those that required intensive care (e.g., respiratory rate ≥30/min, oxygen saturation ≤93%, presence of bilateral lung infiltrates >50% of the lung field); children; pregnant women; baseline 25(OH)D were above 75 nmol/L; SARS-CoV-2 negative and/or SARS-CoV-2 positive but asymptomatic (for home isolation) |
| Interventions | |
| Treatment
Vitamin D 5000 IU 5000 IU orally once daily for 2 weeks (containing 125 mcg vitamin D3) |
|
| Control
Vitamin D 1000 IU ( / ) | |
| Participants | |
| Randomized 73 participants (n1=38 / n2= 35) | |
| Characteristics of participants N=73 Mean age : 49.8 34 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register NR | |
| In the report Number of days to resolve symptoms | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
|
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment | The published article was used in data extraction and risk of bias assessment. The study registry was not accessable and a protocol or statistical analysis plan were not available. Consequently, we cannot tell if the study was analysed as planned. |