Vitamin D Testing and Treatment for COVID 19

Vitamin D Deficiency Clinical Trial

Official title:

Vitamin D Testing and Treatment for Adults With COVID 19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04407286
• Other study ID #: STUDY00011960
• Status: Completed
• Phase: Phase 1
• Start date: May 19, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: December 2021
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid 19
• COVID-19
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D3
Oral vitamin D3 capsules

Locations

Country	Name	City	State
United States	Arizona State University	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	Southwest College of Naturopathic Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D levels	change in level of Vitamin D, 25-Hydroxy between the two time points	baseline and after two weeks of vitamin D supplementation
Primary	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	baseline and at 2 weeks after vitamin D supplementation