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Trial record 1 of 46 for:    Zinc | Covid19
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Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India

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ClinicalTrials.gov Identifier: NCT04641195
Recruitment Status : Not yet recruiting
First Posted : November 23, 2020
Last Update Posted : November 23, 2020
Sponsor:
Collaborators:
Foundation for Medical Research
University Health Network, Toronto
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health

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 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 the hospital at 8 weeks and longer-term symptoms are assessed at 3 months.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : December 7, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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




Primary Outcome Measures :
  1. Time to recovery [ Time Frame: Up to 8 weeks ]
    Defined as resolution of fever, cough and shortness of breath relative to baseline


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Up to 8 weeks ]
  2. Necessity for assisted ventilation [ Time Frame: Up to 8 weeks ]
  3. Individual symptoms duration [ Time Frame: Up to 8 weeks ]
  4. Vitamin D [ Time Frame: At 8 weeks ]
  5. Zinc [ Time Frame: At 8 weeks ]
  6. Interleukin 6 (IL-6) [ Time Frame: At 8 weeks ]
  7. Angiopoietin-2 [ Time Frame: At 8 weeks ]
  8. sTREM-1 [ Time Frame: At 8 weeks ]
  9. Immunoglobulin M (IgM) [ Time Frame: At 8 weeks ]
  10. Immunoglobulin (IgG) [ Time Frame: At 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged >=18 years old
  • Polymerase chain reaction (PCR)-confirmed infection with SARS-COV2
  • Oxygen saturation level of 90 or above
  • Provide informed consent

Exclusion Criteria:

  • Pregnancy
  • Enrollment in other clinical trials
  • Daily use of multivitamins for the past 1 month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04641195


Contacts
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Contact: Wafaie W Fawzi, MBBS, MPH, MS, DrPH 617 432 2086 mina@hsph.harvard.edu
Contact: Kevin Kain, MD Kevin.Kain@uhn.ca

Locations
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India
Saifee Hospital
Mumbai, Maharashtra, India
Contact: Guaray Gupta, MD    +91 9867220473    dr.gauravgupta@gmail.com   
King Edward Memorial (KEM) Hospital
Pune, Maharashtra, India
Sponsors and Collaborators
Harvard School of Public Health
Foundation for Medical Research
University Health Network, Toronto
Investigators
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Principal Investigator: Wafaie W Wafaie, MBBS, MPH, MS, DrPH Harvard School of Public Health
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Responsible Party: Wafaie Fawzi, Professor of Nutrition, Epidemiology, and Global Health, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT04641195    
Other Study ID Numbers: VR3- 172649
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wafaie Fawzi, Harvard School of Public Health:
COVID-19
Vitamin-D3
Zinc
Nutrition support
Host-directed therapy
Clinical management
India
Additional relevant MeSH terms:
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Zinc
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Trace Elements