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

Sponsor

University of Lahore (Other)

Overall Status

Completed

CT.gov ID

NCT04682574

Collaborator

(none)

278

Enrollment

Location

Arms

16.2

Actual Duration (Months)

17.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Corona Virus Infection	Drug: Vitamin C	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

278 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 2, 2020

Actual Primary Completion Date :

Feb 28, 2022

Actual Study Completion Date :

Mar 10, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Partial pressure of Oxygen in arterial blood to fraction of inspired Oxygen (P/F ratio) [1 and 4th day]
Survival analysis [28 days follow up]

Secondary Outcome Measures

Length of Hospital stay [Admission to discharge]
Need for intubation [28 days]
number of intubations needed in both groups.
Inflammatory markers [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.
APACHE II score [before the start of treatment (day 1) and on day 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

critically ill patients admitted in ICU

Exclusion Criteria:

allergic to Vitamin C didnt given the consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bahria Town International Hospital	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

University of Lahore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Muhammad Mansoor Hafeez, Doctor, University of Lahore

ClinicalTrials.gov Identifier:

NCT04682574

Other Study ID Numbers:

IRBEC/BIH/09-2020

First Posted:

Dec 23, 2020

Last Update Posted:

May 6, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronavirus Infections

Ascorbic Acid

Study Results

No Results Posted as of May 6, 2022