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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04641195
• Other study ID #: VR3- 172649
• Status: Completed
• Phase: Phase 3
• Start date: April 22, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2022
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: August 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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
• Zinc (zinc gluconate)
40mg of zinc gluconate taken once per day from enrollment to 8 weeks
• 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.

Locations

Country	Name	City	State
India	Saifee Hospital	Mumbai	Maharashtra
India	King Edward Memorial (KEM) Hospital	Pune	Maharashtra

Sponsors (3)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	Foundation for Medical Research, University Health Network, Toronto

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recovery	Defined as resolution of fever, cough and shortness of breath relative to baseline	Up to 8 weeks
Secondary	All-cause mortality		Up to 8 weeks
Secondary	Necessity for assisted ventilation		Up to 8 weeks
Secondary	Individual symptoms duration		Up to 8 weeks
Secondary	Vitamin D		At 8 weeks
Secondary	Zinc		At 8 weeks
Secondary	Interleukin 6 (IL-6)		At 8 weeks
Secondary	Angiopoietin-2		At 8 weeks
Secondary	sTREM-1		At 8 weeks
Secondary	Immunoglobulin M (IgM)		At 8 weeks
Secondary	Immunoglobulin (IgG)		At 8 weeks
Secondary	Duration of hospital stay		Up to 8 weeks