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

President and Fellows of Harvard College

Status and phase: Completed; Phase 3

Conditions: COVID-19

Treatments: Dietary Supplement: Zinc (zinc gluconate); Other: Placebo; Dietary Supplement: Vitamin D3 (cholecalciferol); Dietary Supplement: Zinc (zinc gluconate) & Vitamin D (cholecalciferol)

Study type: Interventional

Funder types: Other

Identifiers

NCT04641195

VR3- 172649

Details and patient eligibility

About

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.

Full 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.

Enrollment: 181 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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181 participants in 4 patient groups, including a placebo group

Placebo- Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Vitamin D- Placebo

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D3 (cholecalciferol)

Placebo-Zinc

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Zinc (zinc gluconate)

Vitamin D- Zinc

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Zinc (zinc gluconate) & Vitamin D (cholecalciferol)