Trial NCT04449718
Publication Murai IH, Jama (2021) (published paper)
Dates: 2020-06-02 to 2020-08-27
Funding: Public/non profit (Sao Paulo Research Foundation (FAPESP); Conselho Nacional de Desenvolvimento Cientifico e Tecnologico)
Conflict of interest: No

Methods
RCT
Blinding: Double blinded, no restrictions
Location : Multicenter / Brazil
Follow-up duration (days): 40
Inclusion criteria
  • age 18 years or older
  • diagnosis of COVID-19 via PCR testing for SARS-CoV-2 from nasopharyngeal swabs or computed tomography scan findings compatible with the disease (bilateral multifocal ground-glass opacities ≥50%)
  • and diagnosis of flu syndrome with institutional criteria for hospitalization on hospital admission, presenting respiratory rate greater than 24/min, saturation less than 93%while breathing room air, or risk factors for complications (eg, heart disease, diabetes, systemicarterialhypertension,neoplasms, immunosuppression, pulmonary tuberculosis, obesity)followed by COVID-19confirmation.
Exclusion criteria
  • 1) patient unable to read and sign the written informed consent

  • 2) patient already admitted under invasive mechanical ventilation

  • 3) previous vitamin D3 supplementation (> 1000 IU/day)

  • 4) renal failure requiring dialysis or creatinine ≥ 2.0 mg/dL

  • 5) hypercalcemia defined by total calcium > 10.5 mg/dL

  • 6) pregnant or lactating women
  • and
    7) patients with expected hospital discharge in less than 24 hours.
Interventions
Treatment
Cholecalciferol
200 000 IU orally dissolved in 10 mL of peanut oil solution once off
Control
Placebo

Participants
Randomized
participants :
Cholecalciferol =120
Placebo=120
Characteristics of participants
N= 240
Mean age : NR
133 males
Severity : Mild: n=25 / Moderate: n=181 / Severe: n=31 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Length of hospitalization [ Time Frame: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month ]
In the report
Hospital length of stay, defined as the total number of days that patients remained hospitalized from the date of randomization until the date of hospital discharge.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

Yes
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 In addition to the published/pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Although the article states that the protocol and statistical analysis plan will be available as supplements, these were not available at time of data extraction. Other than one outcome reported in the registry but not the article (physical activity), there were no substantive differences between the pre-print article and the trial registry in procedures, population, treatments and outcomes.
The study was updated on March 25th, 2021 with data from Jama.