Status:
UNKNOWN
Oral 25-hydroxyvitamin D3 and COVID-19
Lead Sponsor:
Tehran University of Medical Sciences
Collaborating Sponsors:
Boston University
Conditions:
COVID 19
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this clinical trial is to investigate the therapeutic efficacy of rapidly correcting vitamin D deficiency in adults with the use of 25-hydroxyvitamin D3 \[25(OH)D3\] for reducing the risk ...
Detailed Description
Improvement in the vitamin D status i.e. total serum 25-hydroxyvitamin D in children and adults has been associated with reduced risk of upper respiratory tract infections including influenza A infect...
Eligibility Criteria
Inclusion
- Older than 18 years old and younger than 75 years old for all study groups.
- Meet the diagnostic criteria of COVID-19 for different types (including ordinary type, heavy type and critical type) in infected patients.
- No medications or disorders that would affect vitamin D metabolism
- Women must be on birth control and not pregnant
- Ability and willingness to give informed consent and comply with protocol requirements
Exclusion
- Ongoing treatment with pharmacologic doses of vitamin D, vitamin D metabolites or analogues
- Pregnant or lactating women;
- Severe underlying diseases, such as advanced malignant tumors, endstage lung disease, etc.
- History of elevated serum calcium \>10.6 mg/dl; that is corrected for albumin concentration or subjects with a history of hypercalciuria and kidney stones.
- Chronic hepatic dysfunction, chronic kidney disease or intestinal malabsorption syndromes including inflammatory bowel disease.
- 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 vitamin D metabolism or absorption (anticonvulsants, anti-tuberculosis medication glucocorticoids, HIV medications and cholestyramine).
- Subjects with a history of an adverse reaction to orally administered vitamin D, vitamin D metabolites or analogues.
- Subjects with a history of conditions that can lead to high serum calcium levels such as sarcoidosis, tuberculosis and some lymphomas associated with activated macrophages which increase the production of 1,25(OH)2D.
- Inability to give informed consent
Key Trial Info
Start Date :
April 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2021
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT04386850
Start Date
April 14 2020
End Date
March 15 2021
Last Update
June 12 2020
Active Locations (1)
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1
Tehran University of Medical Sciences
Tehran, Iran