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
|Condition or disease||Intervention/treatment||Phase|
|Covid 19 Vitamin D Deficiency||Dietary Supplement: Vitamin D3||Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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)|
|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|
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
- 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
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
|Contact: Jasmine Kirby, BS||480 234 firstname.lastname@example.org|
|Contact: James B. Adams, PhD||480 965 email@example.com|
|United States, Arizona|
|Arizona State University||Recruiting|
|Tempe, Arizona, United States, 85287|
|Contact: Jasmine Kirby, BS 480-234-3767 firstname.lastname@example.org|
|Contact: James B Adams, PhD 480 965 3316 email@example.com|
|Principal Investigator: James B Adams, PhD|
|Principal Investigator: Sarah Trahan, NMD|
|Principal Investigator:||James B Adams, PhD||Arizona State University|
|Principal Investigator:||Sarah Trahan, NMD||Southwest College of Naturopathic Medicine|