Clinical trial NCT04641195: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Keywords: COVID-19
Vitamin-D3
Zinc
Nutrition support
Host-directed therapy
Clinical management
India
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Foundation for Medical Research
name: University Health Network, Toronto
First posted: 2020-11-23
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The effect of both interventions (vitamin D or zinc) will be investigated simultaneously using a factorial design.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to recovery
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: All-cause mortality
timeFrame: Up to 8 weeks
measure: Necessity for assisted ventilation
timeFrame: Up to 8 weeks
measure: Individual symptoms duration
timeFrame: Up to 8 weeks
measure: Vitamin D
timeFrame: At 8 weeks
measure: Zinc
timeFrame: At 8 weeks
measure: Interleukin 6 (IL-6)
timeFrame: At 8 weeks
measure: Angiopoietin-2
timeFrame: At 8 weeks
measure: sTREM-1
timeFrame: At 8 weeks
measure: Immunoglobulin M (IgM)
timeFrame: At 8 weeks
measure: Immunoglobulin (IgG)
timeFrame: At 8 weeks
measure: Duration of hospital stay
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Saifee Hospital
state: Maharashtra
city: Pune
country: India
facility: King Edward Memorial (KEM) Hospital
state: Maharashtra
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Wafaie W Wafaie, MBBS, MPH, MS, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
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.