Back to resultsVit D3 for Early Symptoms of COVID-19
Primary Purpose
Covid19
Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Standard of care
Vitamin D3
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
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
Sites / Locations
- Ayub Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of care
Investigational treatment
Arm Description
This arm will receive the standard of care as per the hospital guidelines.
This arm will receive vitamin D3 supplement as add-on to the standard of care.
Outcomes
Primary Outcome Measures
SARS-CoV-2 Negativity by RT-PCR
The numbers of patients that tests COVID-19 negative
COVID-19 symptoms improvement
The numbers of patients whose COVID-19 symptoms are subsided
Secondary Outcome Measures
Changes in CRP level
Improvement in blood CRP level
Changes in D-dimer level
Improvement in blood D-dimer level
Changes in LDH level
Improvement in blood LDH level
Changes in ferritin level
Improvement in blood ferritin level
Changes in full blood count
Improvement in full blood count
Full Information
NCT ID
NCT05008003
First Posted
August 11, 2021
Last Updated
March 22, 2022
Sponsor
Ayub Teaching Hospital
Collaborators
Liaquat University of Medical & Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05008003
Brief Title
Vit D3 for Early Symptoms of COVID-19
Official Title
Vit D3 Adjuvant Therapy for Early Mild Symptoms of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2, 2022 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ayub Teaching Hospital
Collaborators
Liaquat University of Medical & Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
This arm will receive the standard of care as per the hospital guidelines.
Arm Title
Investigational treatment
Arm Type
Experimental
Arm Description
This arm will receive vitamin D3 supplement as add-on to the standard of care.
Intervention Type
Drug
Intervention Name(s)
Standard of care
Intervention Description
Standard of care treatment as per the hospital guidelines
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
A daily dose of 5000 IU vitamin D3 for 7 days.
Primary Outcome Measure Information:
Title
SARS-CoV-2 Negativity by RT-PCR
Description
The numbers of patients that tests COVID-19 negative
Time Frame
From day 1 to day 14
Title
COVID-19 symptoms improvement
Description
The numbers of patients whose COVID-19 symptoms are subsided
Time Frame
From day 1 to day 14
Secondary Outcome Measure Information:
Title
Changes in CRP level
Description
Improvement in blood CRP level
Time Frame
From day 1 to day 14
Title
Changes in D-dimer level
Description
Improvement in blood D-dimer level
Time Frame
From day 1 to day 14
Title
Changes in LDH level
Description
Improvement in blood LDH level
Time Frame
From day 1 to day 14
Title
Changes in ferritin level
Description
Improvement in blood ferritin level
Time Frame
From day 1 to day 14
Title
Changes in full blood count
Description
Improvement in full blood count
Time Frame
From day 1 to day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Zeeshan Haroon, MBBS
Phone
+ 92 317 5564317
Email
zeeshanharoon@yahoo.com
Facility Information:
Facility Name
Ayub Teaching Hospital
City
Abbottabad
State/Province
Khyber Pakhtunkhwa
ZIP/Postal Code
22010
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Zeeshan Haroon, MBBS
Phone
+ 92 317 5564317
Email
zeeshanharoon@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vit D3 for Early Symptoms of COVID-19
We'll reach out to this number within 24 hrs