Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India
Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India
The purpose of this study is to assess the effect of vitamin D and/or zinc supplementation on
 improving COVID-19 treatment outcomes. The effects of vitamin D, zinc, and both vitamin D and
 zinc together will be investigated among COVID-19 patients in India.
This study is a 2x2 factorial randomized double-blind, placebo-controlled trial to examine
 the effectiveness of vitamin D and zinc supplements as immune-based therapy among COVID-19
 patients in India. The study is also examining the immunological response to COVID-19 and the
 effect of the intervention on specific biomarkers of immune and endothelial activation that
 are independent and quantitative predictors of severity and mortality in other severe
 infections. The primary aims are to determine the effect of vitamin D supplementation versus
 placebo on time to recovery among patients hospitalized with COVID-19; and to determine the
 effect of zinc supplementation versus placebo on time to recovery among patients hospitalized
 with COVID-19. As secondary aims, this study is also investigating the effect of vitamin D or
 zinc supplementation on all-cause mortality. necessity for assisted ventilation, individual
 symptoms duration and biomarkers including vitamin D, Zinc, Interleukin 6 (IL-6),
 Angiopoietin-2, sTREM-1, immunoglobulin G (IgG) and immunoglobulin M (IgM).

 Eligible individuals are randomly assigned to one of four groups: (1) Vitamin D (180,000 IU
 bolus at enrollment, followed by 2000 IU daily); (2) Zinc (placebo at enrollment followed by
 one daily dose of 40 mg); (3) Vitamin D and Zinc; or (4) Placebo. Daily supplements start at
 the hospital and continue after discharge for a total of 8 weeks. Active data collection
 occurs daily while patients are hospitalized and at least twice per week via telephone after
 discharge. A clinical exam occurs at the hospital at 8 weeks and longer-term symptoms are
 assessed at 3 months.
Inclusion Criteria:

 -  Aged >=18 years old

 -  Polymerase chain reaction (PCR)-confirmed infection with SARS-COV2

 -  Oxygen saturation level of 90 or above

 -  Provide informed consent

 Exclusion Criteria:

 -  Pregnancy

 -  Enrollment in other clinical trials

 -  Daily use of multivitamins for the past 1 month