Vit D3 for Early Symptoms of COVID-19

Not Applicable

• Conditions: Covid19
• Interventions: Drug: Standard of care; Dietary Supplement: Vitamin D3

• Registration Number: NCT05008003
• Lead Sponsor: Ayub Teaching Hospital

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.

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 Timeline

• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-13
• Study First Posted: 2021-08-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-04-04
• Study Start: 2022-09-02
• Primary Completion: 2023-03-01
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational treatment	Vitamin D3	This arm will receive vitamin D3 supplement as add-on to the standard of care.
Investigational treatment	Standard of care	This arm will receive vitamin D3 supplement as add-on to the standard of care.
Standard of care	Standard of care	This arm will receive the standard of care as per the hospital guidelines.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in CRP level	From day 1 to day 14	Improvement in blood CRP level
Changes in full blood count	From day 1 to day 14	Improvement in full blood count
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

Trial Locations

Locations (1)

Ayub Teaching Hospital; 🇵🇰 Abbottabad, Khyber Pakhtunkhwa, Pakistan