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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
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid 19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
May 19, 2020
Last Updated
December 29, 2021
Sponsor
Arizona State University
Collaborators
Southwest College of Naturopathic Medicine
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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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