Vitamin D Testing and Treatment for COVID 19

Study Overview
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Brief Summary
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This study will measure vitamin D levels in adults with COVID 19. Participants with low levels of vitamin D will be entered into an open label trial of supplementation with vitamin D.

Detailed Description
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Protocol for Part 1: 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).

Official Title
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Vitamin D Testing and Treatment for Adults With COVID 19

Conditions
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Covid 19, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Part 1 (testing): Adult age 18 or older Previous positive test result for COVID 19 Able to communicate clearly in English Exclusion Criteria for Part 1 (testing): none Inclusion Criteria for Part 2 (Vitamin D supplementation) Participation in Part 1 Vitamin D level below 30 ng/ml 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 for Part 2 (Vitamin D supplementation): Liver impairment Clinical opinion of study physician that vitamin D supplementation could be harmful to the participant. Pregnancy No symptoms for 2 weeks after positive COVID 19 test Recovered from symptoms

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is an open label treatment study for people with COVID 19 and low levels of vitamin D
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>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. | Dietary Supplement: Vitamin D3<br>* Oral vitamin D3 capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D levels | change in level of Vitamin D, 25-Hydroxy between the two time points | baseline and after two weeks of vitamin D supplementation | 
| severity of COVID 19 symptoms | We will calculate the change in severity of COVID 19 symptoms from baseline to 2 weeks after vitamin D supplementation | baseline and at 2 weeks after vitamin D supplementation |