Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India

  • STATUS
    Recruiting
  • End date
    Mar 31, 2022
  • participants needed
    700
  • sponsor
    Harvard School of Public Health
Updated on 8 May 2021

Summary

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.

Description

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.

Details
Condition *COVID-19, Covid-19
Treatment Placebo, Vitamin D3 (cholecalciferol), Zinc (zinc gluconate), Zinc (zinc gluconate) & Vitamin D (cholecalciferol)
Clinical Study IdentifierNCT04641195
SponsorHarvard School of Public Health
Last Modified on8 May 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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