Vit D3 for Early Symptoms of COVID-19

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Covid19
• Intervention / Treatment: Drug: Standard of care; Dietary supplement: Vitamin D3

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Zeeshan Haroon, MBBS; Phone Number: + 92 317 5564317; Email: zeeshanharoon@yahoo.com

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Abbottabad, Khyber Pakhtunkhwa, Pakistan, 22010
      • Ayub Teaching Hospital
      • Contact: Dr. Zeeshan Haroon, MBBS; Phone Number: + 92 317 5564317; Email: zeeshanharoon@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in CRP level	Improvement in blood CRP level	From day 1 to day 14
Changes in D-dimer level	Improvement in blood D-dimer level	From day 1 to day 14
Changes in LDH level	Improvement in blood LDH level	From day 1 to day 14
Changes in ferritin level	Improvement in blood ferritin level	From day 1 to day 14
Changes in full blood count	Improvement in full blood count	From day 1 to day 14

Collaborators and Investigators

• Sponsor: Ayub Teaching Hospital
• Collaborators: Liaquat University of Medical & Health Sciences

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 2, 2022
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): April 30, 2023

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (ACTUAL): August 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: CQC/COVID/08-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No