Trial NCT04459247
Publication SHADE - Rastogi A, Postgrad Med J (2020) (published paper)

Funding: No specific funding (None)
Conflict of interest: No

Methods
RCT
Blinding: Double blinded, no restrictions
Location : Single center / India
Follow-up duration (days): 21
Inclusion criteria
  • 1) Individuals with SARS-CoV-2 infection who were mildly symptomatic or asymptomatic with or without co-morbidities (hypertension, diabetes mellitus, chronic obstructive airway disease, chronic liver disease, chronic kidney disease)
    2) Patients with vitamin D deficiency defined as 25 (OH)D level<20 ng/ml
Exclusion criteria
  • 1) Patients unable to take oral supplementation like those requiring invasive ventilation or with significant comorbidities like uncontrolled hyperglycaemia or hypertension.
Interventions
Treatment
Cholecalciferol
60 000 IU orally once a day for 7 days, afterwards once a week or once a day for another 7 days (if 25 (OH)D level>50 ng/ml).

Control
Placebo

Participants
Randomized
participants :
Cholecalciferol =16
Placebo=24
Characteristics of participants
N= 40
Mean age : NR
20 males
Severity : Mild: n=40 / Moderate: n=0 / Severe: n=0 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Virus negativity [ Time Frame: 21 days ]
In the report
Proportions of participants who turn SARS-CoV-2 negative(confirmed twice at 24-hour inter val) before week 3
Documents
available

Protocol

NR

Statistical plan

NR

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
*
General comment This study is pending contact with authors.

In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias. There were some differences between trial registry and published article in terms of population inclusion criteria. There were no differences in terms of study procedures, treatments and outcomes. Patient selection, study procedures and treatments are poorly described in both the published article and trail registry. There is no information about co-interventions given to participants as part of standard care. The study achieved its target sample size.