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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

Tracking Information
First Submitted Date  ICMJE May 19, 2020
First Posted Date  ICMJE May 29, 2020
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE May 19, 2020
Estimated Primary Completion Date October 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Testing and Treatment for COVID 19
Official Title  ICMJE Vitamin D Testing and Treatment for Adults With COVID 19
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Covid 19
  • Vitamin D Deficiency
Intervention  ICMJE Dietary Supplement: Vitamin D3
Oral vitamin D3 capsules
Study Arms  ICMJE 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.

Intervention: Dietary Supplement: Vitamin D3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 18, 2021
Estimated Primary Completion Date October 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jasmine Kirby, BS 480 234 3767 jkkirby1@asu.edu
Contact: James B. Adams, PhD 480 965 3316 jim.adams@asu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04407286
Other Study ID Numbers  ICMJE STUDY00011960
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Contact us if you wish to discuss sharing of de-identified data
Responsible Party Arizona State University
Study Sponsor  ICMJE Arizona State University
Collaborators  ICMJE Southwest College of Naturopathic Medicine
Investigators  ICMJE
Principal Investigator: James B Adams, PhD Arizona State University
Principal Investigator: Sarah Trahan, NMD Southwest College of Naturopathic Medicine
PRS Account Arizona State University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP