Role of Mega Dose of Vitamin C in Critical COVID-19 Patients

May 2, 2022 updated by: Muhammad Mansoor Hafeez, University of Lahore

Effects of Mega Dose Vitamin C in Critically Ill COVID-19 Patients: A Randomized Control Trial

Vitamin C (ascorbic acid) is a water-soluble vitamin having anti-inflammatory, immunomodulatory, anti-oxidative, antithrombotic and antiviral properties. Considering these effects vitamin C should have beneficial impact in patients suffering from sepsis and acute respiratory distress syndrome (ARDS). The current study is designed to assess the beneficial effects of Vitamin C in COVID-19 infected patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Bahria Town International Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

critically ill patients admitted in ICU

Exclusion Criteria:

allergic to Vitamin C didnt given the consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: vitamin C
The dose would be 30 grams a day (10 grams TDS) for 3 days with standard treatment
Drug: Vitamin C
mega dose is given to the selected critically ill patients
NO_INTERVENTION: Placebo
Distill water in the same dose with same standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Partial pressure of Oxygen in arterial blood to fraction of inspired Oxygen (P/F ratio)
Time Frame: 1 and 4th day
1 and 4th day
Survival analysis
Time Frame: 28 days follow up
28 days follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital stay
Time Frame: Admission to discharge
Admission to discharge
Need for intubation
Time Frame: 28 days
number of intubations needed in both groups.
28 days
Inflammatory markers
Time Frame: before the start of treatment (day 1) and on day 4
comparison of the inflammatory markers, CRP, D.Dimer, Procalcitonin, LDH, TLC and hematological variables at day four after the intervention started.
before the start of treatment (day 1) and on day 4
APACHE II score
Time Frame: before the start of treatment (day 1) and on day 4
before the start of treatment (day 1) and on day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 2, 2020

Primary Completion (ACTUAL)

February 28, 2022

Study Completion (ACTUAL)

March 10, 2022

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (ACTUAL)

December 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 2, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBEC/BIH/09-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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