Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2020-05-19
2020-11-30
Brief Summary
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Detailed Description
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* A single blood draw at SCNM to measure levels of vitamin D and other nutrients, comprehensive metabolic panel, and complete blood count with differential
* Completing a medical history/symptom form
* Completing a form about COVID-19 symptoms every 2 weeks for 6 weeks
* Authorization for release of medical records related to COVID 19 testing and/or treatment.
Protocol for Part 2:
* Take a vitamin D supplement daily for two weeks, at a dosage of 10,000 IU/day b.i.d. (age 18-69 years) or 15,000 IU/day t.i.d. (age 70+)
* After two weeks of taking vitamin D, return to SCNM for a blood draw to remeasure levels of vitamin D, comprehensive metabolic panel, and complete blood count with differential. If vitamin D levels are still below 30 ng/ml, continue the dosage for 3 more weeks. If vitamin D levels are 30-49 ng/ml, continue at a dosage of 5000 IU/day. If vitamin D levels are 50+ ng/ml, stop supplementation.
* Completing questionnaires about COVID 19 symptoms at 2, 4, and 6 weeks after treatment begins (5 minutes each time).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
This group will receive vitamin D.
The dosage for the first two weeks will be 10,000 IU/day b.i.d. (age 18-69 years) or 15,000 IU/day t.i.d. (age 70+)
After two weeks of taking vitamin D, if vitamin D levels are still below 30 ng/ml, continue the dosage for 3 more weeks. If vitamin D levels are 30-49 ng/ml, continue at a dosage of 5000 IU/day. If vitamin D levels are 50+ ng/ml, stop supplementation.
Vitamin D3
Oral vitamin D3 capsules
Interventions
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Vitamin D3
Oral vitamin D3 capsules
Eligibility Criteria
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Inclusion Criteria
2. Previous positive test result for COVID 19
1. Participation in Part 1
2. Vitamin D level below 30 ng/ml
3. No abnormalities on the comprehensive metabolic panel that are clinically significant to increasing the risk of an adverse reaction to vitamin D supplementation
Exclusion Criteria
2. Clinical opinion of study physician that vitamin D supplementation could be harmful to the participant.
3. Pregnancy
4. No symptoms for 2 weeks after positive COVID 19 test
5. Recovered from symptoms
18 Years
ALL
No
Sponsors
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Southwest College of Naturopathic Medicine
OTHER
Arizona State University
OTHER
Responsible Party
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Principal Investigators
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James B Adams, PhD
Role: PRINCIPAL_INVESTIGATOR
Arizona State University
Sarah Trahan, NMD
Role: PRINCIPAL_INVESTIGATOR
Southwest College of Naturopathic Medicine
Locations
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Arizona State University
Tempe, Arizona, United States
Countries
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Other Identifiers
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STUDY00011960
Identifier Type: -
Identifier Source: org_study_id