Evaluation of the efficacy of oral 25-hydroxyvitamin D3 on COVID-19

Phase 3

Recruiting

Conditions: COVID-19.
SARS-associated coronavirus as the cause of diseases classified elsewhere
U07.1

Registration Number: IRCT20200401046909N2

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 540

Inclusion Criteria

Non-infected with COVID-19 (based on WHO criteria)
Older than 17 years old and younger than 76 years old
No medications or disorders that would affect vitamin D metabolism
Women must be not pregnant at baseline and during study
Ability and willingness to give informed consent and comply with protocol requirements

Exclusion Criteria

Ongoing treatment with pharmacologic doses of vitamin D, vitamin D metabolites or analogs
Pregnant or lactating women
Severe underlying diseases, such as an advanced malignant tumor, end-stage lung disease, etc.
History of elevated serum calcium levels more than 10.6 mg/dl
History of chronic hepatic, renal failure or patients with reduced kidney function, cancers, malabsorption syndrome, or granulomatous disorders such as Sarcoidosis or Tuberculosis
Supplementation with over the counter formulations of vitamin D2 or vitamin D3
Use of tanning bed or artificial UV exposure within the last two weeks
Consuming medication affecting bone metabolism (anti-convulsants, anti-tuberculosis medication, cimetidine, theophylline, and cholestyramine)
Following special diets such as vegetarian diet or consuming fortified products regularly
A history of an adverse reaction to orally administered vitamin D, vitamin D metabolites or analogs
Inability to give informed consent

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Affected by COVID-19. Timepoint: Sign of COVID-19 during study. Method of measurement: patients over 18 years of age with acute respiratory tract infection symptoms (e.g. fever, cough, dyspnea) with no other etiology that fully explains the clinical presentation accompanied by chest computed tomography (CT) scan findings compatible with Covid-19 or definite diagnosis of Covid-19 with real-time polymerase chain reaction (PCR).

Secondary Outcome Measures

Name	Time	Method
Infection duration. Timepoint: During study. Method of measurement: WHO criteria.;Severity of disease (mild, moderate, sever). Timepoint: During study. Method of measurement: Dyspnea, Palsoximethry result, CBC diff, Blood gas parameters, and acid-base, CT scan result.;Serum levels of Vitamin D. Timepoint: Before intervention, end of 4th and end of 8th intervention. Method of measurement: HPLC.