Vitamin D Testing and Treatment for COVID 19

Overview

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

  • 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

Detailed Description

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).

Interventions

  • 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

Primary 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.

3. Pregnancy

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

Investigator Details

  • Lead Sponsor
    • Arizona State University
  • Collaborator
    • Southwest College of Naturopathic Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • 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, jkkirby1@asu.edu

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