Vit D3 for Early Symptoms of COVID-19

NCT ID: NCT05008003

Last Updated: 2022-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-02

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of care

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

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type DRUG

Standard of care treatment as per the hospital guidelines

Investigational treatment

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

Group Type EXPERIMENTAL

Standard of care

Intervention Type DRUG

Standard of care treatment as per the hospital guidelines

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Standard of care

Standard of care treatment as per the hospital guidelines

Intervention Type DRUG

Vitamin D3

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liaquat University of Medical & Health Sciences

OTHER

Sponsor Role collaborator

Ayub Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Umer Farooq

Professor of Community Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ayub Teaching Hospital

Abbottabad, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Dr. Zeeshan Haroon, MBBS

Role: CONTACT

+ 92 317 5564317

Facility Contacts

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Dr. Zeeshan Haroon, MBBS

Role: primary

+ 92 317 5564317

Other Identifiers

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CQC/COVID/08-2021

Identifier Type: -

Identifier Source: org_study_id

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