Vit D3 for Early Symptoms of COVID-19

Sponsor

Ayub Teaching Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05008003

Collaborator

Liaquat University of Medical & Health Sciences (Other)

Enrollment

Location

Arms

7.9

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is aimed to investigate the treatment vitamin D3 as complementary therapy with routine care for early mild symptoms of COVID-19 in outpatients setting.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Standard of care Dietary Supplement: Vitamin D3	N/A

Detailed Description

There is currently no specific early-stage therapeutic treatment available for COVID-19.

Vitamin D3 is a strong antioxidant, and anti-inflammatory/immunomodulatory agent.

The present study is aimed to investigate the treatment benefits of vitamin D3 as add-on therapy to the routine care for early mild symptoms of COVID-19 infection in outpatients setting.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Vit D3 Adjuvant Therapy for Early Mild Symptoms of COVID-19

Anticipated Study Start Date :

Sep 2, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of care This arm will receive the standard of care as per the hospital guidelines.	Drug: Standard of care Standard of care treatment as per the hospital guidelines
Experimental: Investigational treatment This arm will receive vitamin D3 supplement as add-on to the standard of care.	Drug: Standard of care Standard of care treatment as per the hospital guidelines Dietary Supplement: Vitamin D3 A daily dose of 5000 IU vitamin D3 for 7 days.

Arm

Intervention/Treatment

Active Comparator: Standard of care

This arm will receive the standard of care as per the hospital guidelines.

Drug: Standard of care

Standard of care treatment as per the hospital guidelines

Experimental: Investigational treatment

This arm will receive vitamin D3 supplement as add-on to the standard of care.

Drug: Standard of care

Standard of care treatment as per the hospital guidelines

Dietary Supplement: Vitamin D3

A daily dose of 5000 IU vitamin D3 for 7 days.

Outcome Measures

Primary Outcome Measures

SARS-CoV-2 Negativity by RT-PCR [From day 1 to day 14]
The numbers of patients that tests COVID-19 negative
COVID-19 symptoms improvement [From day 1 to day 14]
The numbers of patients whose COVID-19 symptoms are subsided

Secondary Outcome Measures

Changes in CRP level [From day 1 to day 14]
Improvement in blood CRP level
Changes in D-dimer level [From day 1 to day 14]
Improvement in blood D-dimer level
Changes in LDH level [From day 1 to day 14]
Improvement in blood LDH level
Changes in ferritin level [From day 1 to day 14]
Improvement in blood ferritin level
Changes in full blood count [From day 1 to day 14]
Improvement in full blood count

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients must be 18 years of age or older, of either gender
Patients must be tested positive for SARS-CoV-2 by RT-PCR
Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes withshaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc.
Patients must be in the early stage of COVID-19 disease who do not require hospitalization at the time of screening
Patients must be under the care of a Physician for diagnosis of COVID-19
Patients who have signed informed consent

Exclusion Criteria:

Patients with proven hypersensitivity or allergic reaction to quercetin or curcumin
Patients with known chronic kidney disease with estimated creatinine clearance < 50 mL/minute or need for dialysis
Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure
Patients taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin, Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin.
Patients with gallstone obstruction
Hypothyroid suppering patients
Patients with moderate or severe thrombocytopenia (platelet count <100 ×10⁹/L);
Pregnant patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ayub Teaching Hospital	Abbottabad	Khyber Pakhtunkhwa	Pakistan	22010

Sponsors and Collaborators

Ayub Teaching Hospital
Liaquat University of Medical & Health Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Umer Farooq, Professor of Community Medicine, Ayub Teaching Hospital

ClinicalTrials.gov Identifier:

NCT05008003

Other Study ID Numbers:

CQC/COVID/08-2021

First Posted:

Aug 17, 2021

Last Update Posted:

Apr 4, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

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

Additional relevant MeSH terms:

COVID-19

Vitamin D

Cholecalciferol

Study Results

No Results Posted as of Apr 4, 2022