Vitamin D Testing and Treatment for COVID 19

• Sponsor: Arizona State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04407286
• Collaborator: Southwest College of Naturopathic Medicine (Other)
• Enrollment: 41
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.4
• Patients Per Site Per Month: 6.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid 19; Vitamin D Deficiency	Dietary Supplement: Vitamin D3	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• 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 DThis is an open label treatment study for people with COVID 19 and low levels of vitamin D
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vitamin D Testing and Treatment for Adults With COVID 19
• Actual Study Start Date: May 19, 2020
• Actual Primary Completion Date: Aug 30, 2020
• Actual Study Completion Date: Nov 30, 2020

Arms and Interventions

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona State University	Tempe	Arizona	United States	85287

Sponsors and Collaborators

• Arizona State University
• Southwest College of Naturopathic Medicine

Investigators

• Principal Investigator: James B Adams, PhD, Arizona State University
• Principal Investigator: Sarah Trahan, NMD, Southwest College of Naturopathic Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arizona State University
• ClinicalTrials.gov Identifier: NCT04407286
• Other Study ID Numbers: STUDY00011960
• First Posted: May 29, 2020
• Last Update Posted: Dec 30, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Vitamin D Deficiency; Vitamin D; Cholecalciferol

Study Results

No Results Posted as of Dec 30, 2021