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

Investigating preventive effects of oral 25-hydroxyvitamin D3 on COVID-19 in adults: A Randomized, Controlled Double-Blind Clinical Trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200401046909N2
Enrollment
540
Registered
2020-04-11
Start date
2020-04-14
Completion date
Unknown
Last updated
2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19. SARS-associated coronavirus as the cause of diseases classified elsewhere

Interventions

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZhila Maghbooli

Tehran University of Medical Sciences

zhilayas@gmail.com+98 21 6670 6142

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026