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.
Full Title of Study: “Vitamin D Testing and Treatment for Adults With COVID 19″
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: August 18, 2020
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).
- Dietary Supplement: Vitamin D3
- Oral vitamin D3 capsules
Arms, Groups and Cohorts
- Experimental: 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.
Clinical Trial Outcome Measures
- Vitamin D levels
- Time Frame: baseline and after two weeks of vitamin D supplementation
- change in level of Vitamin D, 25-Hydroxy between the two time points
- severity of COVID 19 symptoms
- Time Frame: baseline and at 2 weeks after vitamin D supplementation
- We will calculate the change in severity of COVID 19 symptoms from baseline to 2 weeks after vitamin D supplementation
Participating in This Clinical Trial
Inclusion Criteria for Part 1 (testing):
1. Adult age 18 or older
2. Previous positive test result for COVID 19
3. Able to communicate clearly in English Exclusion Criteria for Part 1 (testing): none
Inclusion Criteria for Part 2 (Vitamin D supplementation)
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 for Part 2 (Vitamin D supplementation):
1. Liver impairment
2. Clinical opinion of study physician that vitamin D supplementation could be harmful to the participant.
4. No symptoms for 2 weeks after positive COVID 19 test
5. Recovered from symptoms
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Arizona State University
- Southwest College of Naturopathic Medicine
- Provider of Information About this Clinical Study
- Overall Official(s)
- James B Adams, PhD, Principal Investigator, Arizona State University
- Sarah Trahan, NMD, Principal Investigator, Southwest College of Naturopathic Medicine
- Overall Contact(s)
- Jasmine Kirby, BS, 480 234 3767, firstname.lastname@example.org
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