Vit D3 for Early Symptoms of COVID-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05008003
• Other study ID #: CQC/COVID/08-2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2022
• Source: Ayub Teaching Hospital
• Contact: Dr. Zeeshan Haroon, MBBS
• Phone: + 92 317 5564317
• Email: zeeshanharoon[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 30, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ×10?/L);
• Pregnant patients

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Ayub Teaching Hospital	Abbottabad	Khyber Pakhtunkhwa

Sponsors (2)

Lead Sponsor	Collaborator
Ayub Teaching Hospital	Liaquat University of Medical & Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 Negativity by RT-PCR	The numbers of patients that tests COVID-19 negative	From day 1 to day 14
Primary	COVID-19 symptoms improvement	The numbers of patients whose COVID-19 symptoms are subsided	From day 1 to day 14
Secondary	Changes in CRP level	Improvement in blood CRP level	From day 1 to day 14
Secondary	Changes in D-dimer level	Improvement in blood D-dimer level	From day 1 to day 14
Secondary	Changes in LDH level	Improvement in blood LDH level	From day 1 to day 14
Secondary	Changes in ferritin level	Improvement in blood ferritin level	From day 1 to day 14
Secondary	Changes in full blood count	Improvement in full blood count	From day 1 to day 14