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

Conditions

COVID-19

Keywords

COVID-19, Vitamin-D3, Zinc, Nutrition support, Host-directed therapy, Clinical management, India

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.

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.

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Interventions

DIETARY_SUPPLEMENTVitamin D3 (cholecalciferol)

180,000 international units (IU) of vitamin D3 at enrollment, followed by 2000 IU once per day from enrollment to 8 weeks

DIETARY_SUPPLEMENTZinc (zinc gluconate)

40mg of zinc gluconate taken once per day from enrollment to 8 weeks

DIETARY_SUPPLEMENTZinc (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

OTHERPlacebo

Placebo vitamin D bolus at enrollment followed by placebo daily vitamin D maintenance doses and placebo daily zinc supplements.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Time to recovery	Up to 8 weeks	Defined as resolution of fever, cough and shortness of breath relative to baseline

Secondary

Measure	Time frame
Necessity for assisted ventilation	Up to 8 weeks
Individual symptoms duration	Up to 8 weeks
Vitamin D	At 8 weeks
Zinc	At 8 weeks
Interleukin 6 (IL-6)	At 8 weeks
All-cause mortality	Up to 8 weeks
sTREM-1	At 8 weeks
Immunoglobulin M (IgM)	At 8 weeks
Immunoglobulin (IgG)	At 8 weeks
Duration of hospital stay	Up to 8 weeks
Angiopoietin-2	At 8 weeks

Countries

India

Outcome results

None listed