A prospective, double-blind, parallel assignment, randomised controlled study to evaluate the effectiveness and safety of high dose Vitamin D supplementation in patients with symptomatic mild to moderate illness of SARS CoV-2 infection and effects and associations of low vitamin D levels in this group
- Conditions
- SARS CoV 2 symptomatic disease
- Registration Number
- SLCTR/2021/019
- Lead Sponsor
- Base Hospital, Homagama
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
Male or female patients
- Aged over 18 years
- Having mild or moderate illness according to the National Institute of Health Classification system for SARS CoV -2
oMild illness: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
oModerate illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have an oxygen saturation (SpO2) greater than or equal to 94% on room air at sea level.
- Laboratory confirmed SARS-CoV-2 symptomatic infection
- Availability of the patient for recruitment into the study within 96 hours of symptom onset
- Normal corrected/ ionized calcium at the time of admission according to the reference range provided by the laboratory
- Pregnant and/or lactating women
- Prior diagnosis of vitamin D deficiency (less than 20 ng/mL)
- Being on vitamin D supplementation greater than 1000 IU/day within past 3 months:
- Organ failure/ need for ICU stay/ organ support at the time of enrollment
- Patients with any disorder related to calcium metabolism that in the opinion of the investigator does not justify a high dose of vitamin D
- Patients who have been already enrolled in any other clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 7-point ordinal scale for clinical improvement in COVID-19 [Ref: Ader, F. (2020) Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults. BMJ open, 10(9), [Online] Available from: doi.org/10.1136/bmjopen-2020-041437.] will be used to define the primary outcome. <br><br>The percentage of participants being in the first three categories will be calculated as the primary outcome measure.<br><br>1. Not hospitalised, no limitation on activities, asymptomatic<br>2. Not hospitalised, limitation on activities <br>3. Hospitalised, not requiring supplemental oxygen <br>4. Hospitalised, requiring supplemental oxygen <br>5. Hospitalised, on non-invasive ventilation or high flow oxygen devices <br>6. Hospitalised, on invasive mechanical ventilation or ECMO <br>7. Death.<br> [Day 14 and 28 from date of admission]<br>
- Secondary Outcome Measures
Name Time Method