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Trial - NCT04482673


Column Value
Trial registration number NCT04482673
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04482673

First author
Last imported at : March 1, 2023, 9:56 a.m.
Source : ClinicalTrials.gov

Carol L. Wagner

Contact
Last imported at : March 1, 2023, 9:56 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-07-22

Recruitment status
Last imported at : March 1, 2023, 9:56 a.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

entry criteria: ---adults aged 50 years of age or older who presents to musc or its affiliate hospitals (or associated testing centers) for covid-19 testing during the recruitment period is eligible for participation.

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- hospitalization at the time of study recruitment. - any individual less than 50 years of age. the reason that the participants ≥50 years are being excluded from this study is because those who are ≥50 years have a higher risk of being symptomatic with covid-19 and have the potential for the greatest benefit. the disease appears to manifest differently in children and its occurrence is quite rare. - only those patients tested for covid-19 initially will be eligible to participate; therefore, anyone wanting to participate in the trial must have had a covid-19 test prior to enrollment/participation in the study. - any individual who is not capable of making independent decisions and who is considered cognitively impaired.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Medical University of South Carolina

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

50

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : March 1, 2023, 9:56 a.m.
Source : ClinicalTrials.gov

95

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Change in total circulating 25(OH)D concentration;Change in total circulating 25(OH)D concentration in COVID-19 positives;Change in SARS-CoV-2 antibody titers

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1371, "treatment_name": "Vitamin d3", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1371, "treatment_name": "Vitamin d3", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]