A prospective, double-blind, parallel assignment, randomised controlled study to evaluate the effectiveness and safety of high dose Vitamin D supplementation and effects and associations of low vitamin D levels in patients with symptomatic SARS CoV-2 infection

Base Hospital, Homagama0 个研究点开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

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•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

发起方

Base Hospital, Homagama