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

Sponsor

Harvard School of Public Health (HSPH) (Other)

Overall Status

Recruiting

CT.gov ID

NCT04641195

Collaborator

Foundation for Medical Research (Other), University Health Network, Toronto (Other)

700

Enrollment

Locations

Arms

17.3

Anticipated Duration (Months)

350

Patients Per Site

20.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Dietary Supplement: Vitamin D3 (cholecalciferol) Dietary Supplement: Zinc (zinc gluconate) Dietary Supplement: Zinc (zinc gluconate) & Vitamin D (cholecalciferol) Other: Placebo	Phase 3

Detailed 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, 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

The effect of both interventions (vitamin D or zinc) will be investigated simultaneously using a factorial design.The effect of both interventions (vitamin D or zinc) will be investigated simultaneously using a factorial design.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized Trial to Determine the Effect of Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India

Actual Study Start Date :

Apr 22, 2021

Anticipated Primary Completion Date :

Jul 29, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo- Placebo Participants in the PLACEBO-PLACEBO group will receive a placebo vitamin D bolus at the hospital followed by placebo daily vitamin D maintenance doses and placebo daily zinc supplements.	Other: Placebo Placebo vitamin D bolus at enrollment followed by placebo daily vitamin D maintenance doses and placebo daily zinc supplements.
Experimental: Vitamin D- Placebo Participants in the VITAMIN D-PLACEBO group will receive an actual vitamin D bolus at the hospital followed by actual daily vitamin D maintenance doses and daily placebo zinc supplements.	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
Experimental: Placebo-Zinc Participants in the PLACEBO-ZINC group will receive a placebo vitamin D bolus at the hospital followed by placebo daily vitamin D maintenance doses and actual daily zinc supplements.	Dietary Supplement: Zinc (zinc gluconate) 40mg of zinc gluconate taken once per day from enrollment to 8 weeks
Experimental: Vitamin D- Zinc Participants in the VITAMIN D-ZINC group will receive an actual vitamin D bolus at the hospital followed by actual daily vitamin D maintenance doses and actual daily zinc supplements.	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