Vitamin D Testing and Treatment for COVID 19
Primary Purpose
Covid 19, Vitamin D Deficiency
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
About this trial
This is an interventional treatment trial for Covid 19
Eligibility Criteria
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
Sites / Locations
- Arizona State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
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.
Outcomes
Primary Outcome Measures
Vitamin D levels
change in level of Vitamin D, 25-Hydroxy between the two time points
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04407286
First Posted
May 19, 2020
Last Updated
December 29, 2021
Sponsor
Arizona State University
Collaborators
Southwest College of Naturopathic Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04407286
Brief Title
Vitamin D Testing and Treatment for COVID 19
Official Title
Vitamin D Testing and Treatment for Adults With COVID 19
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 19, 2020 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
Southwest College of Naturopathic Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid 19, Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
This is an open label treatment study for people with COVID 19 and low levels of vitamin D
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
Oral vitamin D3 capsules
Primary Outcome Measure Information:
Title
Vitamin D levels
Description
change in level of Vitamin D, 25-Hydroxy between the two time points
Time Frame
baseline and after two weeks of vitamin D supplementation
Title
severity of COVID 19 symptoms
Description
We will calculate the change in severity of COVID 19 symptoms from baseline to 2 weeks after vitamin D supplementation
Time Frame
baseline and at 2 weeks after vitamin D supplementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James B Adams, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Trahan, NMD
Organizational Affiliation
Southwest College of Naturopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Contact us if you wish to discuss sharing of de-identified data
Learn more about this trial
Vitamin D Testing and Treatment for COVID 19
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