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

P

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

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)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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