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, duration of hospital stay 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 8 weeks and longer-term symptoms are assessed at 3
months.
Dietary Supplement: Vitamin D3 (cholecalciferol)
180,000 international units (IU) of vitamin D3 at enrollment, followed by 2000 IU once per day from enrollment to 8 weeks
Dietary Supplement: Zinc (zinc gluconate)
40mg of zinc gluconate taken once per day from enrollment to 8 weeks
Dietary Supplement: Zinc (zinc gluconate) & Vitamin D (cholecalciferol)
180,000 IU of vitamin D3 at enrollment, followed by 2000 IU of vitamin D3 and 40mg of zinc gluconate once per day from enrollment to 8 weeks
Other: Placebo
Placebo vitamin D bolus at enrollment followed by placebo daily vitamin D maintenance doses and placebo daily zinc supplements.
Inclusion Criteria:
- Aged >=18 years old
- Polymerase chain reaction (PCR) or Rapid Antigen Test (RAT)-confirmed infection with
SARS-COV2
- Provide informed consent
Exclusion Criteria:
- Pregnancy
- Enrollment in other clinical trials
Saifee Hospital
Mumbai, Maharashtra, India
King Edward Memorial (KEM) Hospital
Pune, Maharashtra, India
Wafaie W Wafaie, MBBS, MPH, MS, DrPH, Principal Investigator
Harvard School of Public Health (HSPH)