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OpenTrials
Completed

NCT Number: NCT04407286

Vitamin D Testing and Treatment for COVID 19

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Part 1 (testing):

  • Adult age 18 or older
  • Previous positive test result for COVID 19
  • Able to communicate clearly in English Exclusion Criteria for Part 1 (testing): none

Inclusion criteria

for Part 2 (Vitamin D supplementation)

  • Participation in Part 1
  • Vitamin D level below 30 ng/ml
  • 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):

  • Liver impairment
  • Clinical opinion of study physician that vitamin D supplementation could be harmful to the participant.
  • Pregnancy
  • No symptoms for 2 weeks after positive COVID 19 test
  • Recovered from symptoms

Treatment and study plan

Vitamin D3

Dietary Supplement

Oral vitamin D3 capsules

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Southwest College of Naturopathic Medicine

Registry information

Official study title

Vitamin D Testing and Treatment for Adults With COVID 19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 29, 2020
Registry last updated
Dec 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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