{"doi":"10.1016/j.cdnut.2023.101971","title":"Vitamin D and Zinc Supplementation to Improve Treatment Outcomes among COVID-19 Patients in India: Results from a Double-Blind Randomized Placebo-Controlled Trial","abstract":"There remains a need to identify low-cost interventions to improve COVID-19 outcomes. Vitamin D and zinc play a role in respiratory infections, and could hold value as part of therapeutic regimens. To determine the effect of vitamin D or zinc supplementation on recovery from COVID-19. We conducted a double-blind randomized 2x2 factorial placebo-controlled trial with 1:1:1:1 allocation ratio, enrolling non-pregnant adults with COVID-19 from hospitals in Mumbai and Pune, India (NCT04641195). Participants (N=181) were randomized to vitamin D3 (180,000IU bolus, then 2000IU daily), zinc (40mg daily), vitamin D3 and zinc, or placebo, for 8 weeks. Participants were followed until 8 weeks. The primary outcome was time to resolution of fever, cough, and shortness of breath. Secondary outcomes were duration of individual symptoms; need for assisted ventilation; duration of hospital stay; all-cause mortality; and blood biomarkers including nutritional, inflammatory and immunological markers. We observed no effect of vitamin D or zinc supplementation on time to resolution of all three symptoms (vitamin D hazard ratio [HR]: 0.92, 95% confidence interval [95% CI]: 0.66-1.30, P=0.650; zinc HR: 0.94, 95% CI: 0.67-1.33, P=0.745). Neither vitamin D nor zinc supplementation was associated with secondary outcomes, except for increased endline serum vitamin D with vitamin D supplementation (median [interquartile range] difference between endline and baseline for vitamin D: 5.3ng/mL [-2.3-13.7]; for no vitamin D: -1.4ng/mL [-5.6-3.9]; P=0.003). We observed non-significant increases in serum zinc at endline following zinc supplementation. There was no evidence of interaction between vitamin D and zinc supplementation; no effect of either on hypercalcemia; and no adverse events. Results suggest that neither vitamin D nor zinc supplementation improve COVID-19 treatment outcomes in this population. However, much larger-scale evidence, particularly from populations with vitamin D or zinc deficiency and severe infection, is required to corroborate our findings. 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