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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
This is an open label treatment study for people with COVID 19 and low levels of vitamin D
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Dietary Supplement: Vitamin D3
    Oral vitamin D3 capsules

Recruiting Locations

More Details

NCT ID
NCT04407286
Status
Completed
Sponsor
Arizona State University

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.