Clinical trial NCT04407286: Vitamin D Testing and Treatment for COVID 19
Official title: Vitamin D Testing and Treatment for Adults With COVID 19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Covid 19
Vitamin D Deficiency
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Southwest College of Naturopathic Medicine
First posted: 2020-05-29
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open label treatment study for people with COVID 19 and low levels of vitamin D
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Vitamin D levels
timeFrame: baseline and after two weeks of vitamin D supplementation
measure: severity of COVID 19 symptoms
timeFrame: baseline and at 2 weeks after vitamin D supplementation
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: James B Adams, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southwest College of Naturopathic Medicine
name: Sarah Trahan, NMD
role: PRINCIPAL_INVESTIGATOR
References: