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Vitamin D Testing and Treatment for COVID 19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407286
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
Southwest College of Naturopathic Medicine
Information provided by (Responsible Party):
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.

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 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
Estimated Primary Completion Date : October 18, 2020
Estimated Study Completion Date : May 18, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Vitamin D levels [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407286


Contacts
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Contact: Jasmine Kirby, BS 480 234 3767 jkkirby1@asu.edu
Contact: James B. Adams, PhD 480 965 3316 jim.adams@asu.edu

Locations
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United States, Arizona
Arizona State University Recruiting
Tempe, Arizona, United States, 85287
Contact: Jasmine Kirby, BS    480-234-3767    jkkirby1@asu.edu   
Contact: James B Adams, PhD    480 965 3316    jim.adams@asu.edu   
Principal Investigator: James B Adams, PhD         
Principal Investigator: Sarah Trahan, NMD         
Sponsors and Collaborators
Arizona State University
Southwest College of Naturopathic Medicine
Investigators
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Principal Investigator: James B Adams, PhD Arizona State University
Principal Investigator: Sarah Trahan, NMD Southwest College of Naturopathic Medicine
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Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT04407286    
Other Study ID Numbers: STUDY00011960
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Contact us if you wish to discuss sharing of de-identified data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents