Randomised trial to determine the effect of vitamin D and zinc supplementation for improving treatment outcomes among patients with COVID-19 in India: trial protocol

Kamal Kant Sharma, Uttara Partap, Nerges Mistry, Yogesh Marathe, Molin Wang, Sanaa Shaikh, Pradeep D'Costa, Gaurav Gupta, Sabri Bromage, Elena C Hemler, Kevin C Kain, Yatin Dholakia, Wafaie W Fawzi, Kamal Kant Sharma, Uttara Partap, Nerges Mistry, Yogesh Marathe, Molin Wang, Sanaa Shaikh, Pradeep D'Costa, Gaurav Gupta, Sabri Bromage, Elena C Hemler, Kevin C Kain, Yatin Dholakia, Wafaie W Fawzi

Abstract

Introduction: Presently, there are few population-level strategies to address SARS-CoV-2 infection except preventive measures such as vaccination. Micronutrient deficiency, particularly vitamin D and zinc deficiency, has been associated with dysregulated host responses, and may play an important role in COVID-19.

Methods and analysis: We have designed a 2×2 factorial, randomised, double-blind, multi-centre placebo-controlled trial to evaluate the effect of vitamin D and zinc on COVID-19 outcomes in Maharashtra, India. COVID-19 positive individuals are recruited from hospitals in Mumbai and Pune. Participants are provided (1) vitamin D3 bolus (180 000 IU) maintained by daily dose of 2000 IU and/or (2) zinc gluconate (40 mg daily), versus placebo for 8 weeks. Participants undergo a detailed assessment at baseline and at 8 weeks, and are monitored daily in hospital or every 3 days after leaving the hospital to assess symptoms and other clinical measures. A final follow-up telephone call occurs 12 weeks post-enrolment to assess long-term outcomes. The primary outcome of the study is to time to recovery, defined as time to resolution of all of fever, cough and shortness of breath. Secondary outcomes include: duration of hospital stay, all-cause mortality, necessity of assisted ventilation, change in blood biomarker levels and individual symptoms duration. Participant recruitment commenced on April 2021.

Ethics and dissemination: Ethical approval was obtained from institutional ethical committees of all participating institutions. The study findings will be presented in peer-reviewed medical journals.

Trial registration numbers: NCT04641195, CTRI/2021/04/032593, HMSC (GOI)-2021-0060.

Keywords: COVID-19; clinical trials; nutrition.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Map of India (grey) with Maharashtra highlighted in red, and Mumbai (black dot) and Pune (blue dot) identified. Map created with mapchart.net.
Figure 2
Figure 2
Overview of trial procedures. RAT: rapid antigen test.

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