NCT05008003

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

September 2, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

August 11, 2021

Last Update Submit

March 22, 2022

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Changes in CRP level

    From day 1 to day 14

  • Changes in D-dimer level

    From day 1 to day 14

  • Changes in LDH level

    From day 1 to day 14

  • Changes in ferritin level

    From day 1 to day 14

  • Changes in full blood count

    From day 1 to day 14

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

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

Drug: Standard of care

Investigational treatment

EXPERIMENTAL

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

Drug: Standard of careDietary Supplement: Vitamin D3

Interventions

Standard of careDRUG

Standard of care treatment as per the hospital guidelines

Investigational treatmentStandard of care
Vitamin D3DIETARY_SUPPLEMENT

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

Investigational treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayub Teaching Hospital

Abbottabad, Khyber Pakhtunkhwa, 22010, Pakistan

Location

MeSH Terms

Conditions

COVID-19

Interventions

Standard of CareCholecalciferol

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Central Study Contacts

Dr. Zeeshan Haroon, MBBS

CONTACT

+ 92 317 5564317zeeshanharoon@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Community Medicine

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 17, 2021

Study Start

September 2, 2022

Primary Completion

March 1, 2023

Study Completion

April 30, 2023

Last Updated

April 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)