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

NCT04641195 | Completed Phase 3 DMC

• 1 other identifier: VR3- 172649
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Keywords

COVID-19; Vitamin-D3; Zinc; Nutrition support; Host-directed therapy; Clinical management; India

Outcome Measures

Primary Outcomes (1)

• Time to recovery

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

  Up to 8 weeks

Secondary Outcomes (11)

• All-cause mortality

  Up to 8 weeks

• Necessity for assisted ventilation

  Up to 8 weeks

• Individual symptoms duration

  Up to 8 weeks

• Vitamin D

  At 8 weeks

• Zinc

  At 8 weeks

Study Arms (4)

Placebo- Placebo

PLACEBO COMPARATOR

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

Vitamin D- Placebo

EXPERIMENTAL

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)

Placebo-Zinc

EXPERIMENTAL

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)

Vitamin D- Zinc

EXPERIMENTAL

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)

Interventions

Vitamin D3 (cholecalciferol) DIETARY_SUPPLEMENT

180,000 international units (IU) of vitamin D3 at enrollment, followed by 2000 IU once per day from enrollment to 8 weeks

Vitamin D- Placebo

Zinc (zinc gluconate) DIETARY_SUPPLEMENT

40mg of zinc gluconate taken once per day from enrollment to 8 weeks

Placebo-Zinc

Zinc (zinc gluconate) & Vitamin D (cholecalciferol) DIETARY_SUPPLEMENT

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

Vitamin D- Zinc

Placebo OTHER

Placebo vitamin D bolus at enrollment followed by placebo daily vitamin D maintenance doses and placebo daily zinc supplements.

Placebo- Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \>=18 years old
• Polymerase chain reaction (PCR) or Rapid Antigen Test (RAT)-confirmed infection with SARS-COV2
• Provide informed consent

You may not qualify if:

• Pregnancy
• Enrollment in other clinical trials

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Foundation for Medical Research: collaborator
• University Health Network, Toronto: collaborator

Study Sites (2)

Saifee Hospital

Mumbai, Maharashtra, India

Location

King Edward Memorial (KEM) Hospital

Pune, Maharashtra, India

Location

Related Publications (3)

• Partap U, Sharma KK, Marathe Y, Wang M, Shaikh S, D'Costa P, Gupta G, Bromage S, Hemler EC, Mistry N, Kain KC, Dholakia Y, Fawzi WW. Vitamin D and Zinc Supplementation to Improve Treatment Outcomes among COVID-19 Patients in India: Results from a Double-Blind Randomized Placebo-Controlled Trial. Curr Dev Nutr. 2023 Jul 11;7(8):101971. doi: 10.1016/j.cdnut.2023.101971. eCollection 2023 Aug.

  PMID: 37560461 DERIVED

• Martineau AR. Vitamin D in the prevention or treatment of COVID-19. Proc Nutr Soc. 2023 May;82(2):200-207. doi: 10.1017/S0029665122002798. Epub 2022 Nov 11.

  PMID: 36366796 DERIVED

• 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.

  PMID: 36038172 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Cholecalciferol; gluconic acid; Zinc; Vitamin D

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Wafaie W Wafaie, MBBS, MPH, MS, DrPH

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition, Epidemiology, and Global Health

Model Details: The effect of both interventions (vitamin D or zinc) will be investigated simultaneously using a factorial design.

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 23, 2020
• Study Start: April 22, 2021
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

IN (2)