Vitamin D Testing and Treatment for COVID 19

Phase 1

Completed

• Conditions: Covid 19; Vitamin D Deficiency
• Interventions: Dietary Supplement: Vitamin D3

• Registration Number: NCT04407286
• Lead Sponsor: Arizona State University

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).

Study Timeline

• Study Start: 2020-05-19
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-29
• Primary Completion: 2020-08-30
• Study Completion: 2020-11-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-29
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Vitamin D3	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.

Primary Outcome Measures

Name	Time	Method
severity of COVID 19 symptoms	baseline and at 2 weeks after vitamin D supplementation	We will calculate the change in severity of COVID 19 symptoms from baseline to 2 weeks after vitamin D supplementation
Vitamin D levels	baseline and after two weeks of vitamin D supplementation	change in level of Vitamin D, 25-Hydroxy between the two time points

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Tempe, Arizona, United States