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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04489628
Other study ID # STUDY20200461
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date August 1, 2020
Est. completion date June 1, 2021

Study information

Verified date February 2022
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the efficacy of high dose Vitamin D (an over-the-counter nutritional supplement) in preventing immune-related complications in outpatients with confirmed SARS-CoV-2 infection.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. = 18 years of age 2. Laboratory confirmed SARS-CoV-2 infection < 4 days before randomization 3. Report of symptoms consistent with SARS-CoV-2 infection (including but not limited to fever, cough, muscle aches, joint pain, change in taste, change in smell, or shortness of breath) <4 days before admission 4. Asymptomatic or mild symptoms (not requiring hospital admission) 5. Access to and ability to use a mobile phone with telehealth capability Exclusion Criteria: 1. Unable to provide informed consent or comply with study directions 2. Admitted to an acute care bed 3. Baseline serum calcium < 8.8 mg/dL or > 10.2 mg/dl (as evaluated by labs taken in the ER/urgent care) 4. Women who are currently breastfeeding 5. History of kidney stone in the past year or h/o multiple (>1) previous kidney stones 6. Does not have a smart phone that can download apps from Google Play or App Store. 7. No way to keep the phone charged consistently 8. The smartphone is shared with another individual. 9. Required laboratory data is unavailable (eg calcium levels) 10. No new oxygen requirement (see remote monitoring document) 11. Pregnant and lactating mothers. 12. Vitamin D level of 80ng/ml and above 13. No lab work for calcium or vitamin D completed in ED

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vitamin D3 or Placebo
): Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.
Device:
Doctella telehealth monitoring
Doctella device will be give to participants by the Emergency department as part of usual care to monitor heart rate, respiratory rate, oxygen saturation, and perfusion index vitals continuously for approximately 10 days. The study team will receive the vitals signs data (heart rate, respiratory rate, oxygen saturation, perfusion index, and temperature) retrospectively and will not be able to monitor patients in real time.

Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patients requiring admission to the hospital or experiencing death Proportion of patients requiring admission to the hospital or experiencing death by Day 15 Days 1 to 15
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