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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Vitamin D3 (cholecalciferol)
Zinc (zinc gluconate)
Zinc (zinc gluconate) & Vitamin D (cholecalciferol)
Placebo
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Vitamin-D3, Zinc, Nutrition support, Host-directed therapy, Clinical management, India

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Saifee Hospital
  • King Edward Memorial (KEM) Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo- Placebo

Vitamin D- Placebo

Placebo-Zinc

Vitamin D- Zinc

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Time to recovery
Defined as resolution of fever, cough and shortness of breath relative to baseline

Secondary Outcome Measures

All-cause mortality
Necessity for assisted ventilation
Individual symptoms duration
Vitamin D
Zinc
Interleukin 6 (IL-6)
Angiopoietin-2
sTREM-1
Immunoglobulin M (IgM)
Immunoglobulin (IgG)
Duration of hospital stay

Full Information

First Posted
November 19, 2020
Last Updated
September 15, 2022
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Foundation for Medical Research, University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04641195
Brief Title
Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Foundation for Medical Research, University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Vitamin-D3, Zinc, Nutrition support, Host-directed therapy, Clinical management, India

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Model Description
The effect of both interventions (vitamin D or zinc) will be investigated simultaneously using a factorial design.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo- Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Vitamin D- Placebo
Arm Type
Experimental
Arm 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.
Arm Title
Placebo-Zinc
Arm Type
Experimental
Arm 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.
Arm Title
Vitamin D- Zinc
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3 (cholecalciferol)
Intervention Description
180,000 international units (IU) of vitamin D3 at enrollment, followed by 2000 IU once per day from enrollment to 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc (zinc gluconate)
Intervention Description
40mg of zinc gluconate taken once per day from enrollment to 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc (zinc gluconate) & Vitamin D (cholecalciferol)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo vitamin D bolus at enrollment followed by placebo daily vitamin D maintenance doses and placebo daily zinc supplements.
Primary Outcome Measure Information:
Title
Time to recovery
Description
Defined as resolution of fever, cough and shortness of breath relative to baseline
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
Up to 8 weeks
Title
Necessity for assisted ventilation
Time Frame
Up to 8 weeks
Title
Individual symptoms duration
Time Frame
Up to 8 weeks
Title
Vitamin D
Time Frame
At 8 weeks
Title
Zinc
Time Frame
At 8 weeks
Title
Interleukin 6 (IL-6)
Time Frame
At 8 weeks
Title
Angiopoietin-2
Time Frame
At 8 weeks
Title
sTREM-1
Time Frame
At 8 weeks
Title
Immunoglobulin M (IgM)
Time Frame
At 8 weeks
Title
Immunoglobulin (IgG)
Time Frame
At 8 weeks
Title
Duration of hospital stay
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wafaie W Wafaie, MBBS, MPH, MS, DrPH
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saifee Hospital
City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
King Edward Memorial (KEM) Hospital
City
Pune
State/Province
Maharashtra
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
36038172
Citation
Sharma KK, Partap U, Mistry N, Marathe Y, Wang M, Shaikh S, D'Costa P, Gupta G, Bromage S, Hemler EC, Kain KC, Dholakia Y, Fawzi WW. Randomised trial to determine the effect of vitamin D and zinc supplementation for improving treatment outcomes among patients with COVID-19 in India: trial protocol. BMJ Open. 2022 Aug 29;12(8):e061301. doi: 10.1136/bmjopen-2022-061301.
Results Reference
derived

Learn more about this trial

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

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