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| Column | Value |
|---|---|
| Trial registration number | NCT04536298 |
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Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-09-02 |
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Recruitment status
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion/exclusion criteria for index cases: inclusion criteria adults aged 18 years or older who are newly diagnosed with covid-19 infection within 7 days of testing. ability and willingness to understand and provide informed consent. exclusion criteria known current pregnancy. current hospitalization. unable to complete online questionnaires or adhere to study requirements. consume more than 1000 iu per day of vitamin d from all supplemental sources combined (individual vitamin d supplements, calcium plus vitamin d supplements, medications with vitamin d [e.g., fosamax plus d], and multivitamins) in the past 4 weeks. use of prescription vitamin d treatments (calcitriol [rocaltrol, calcitrol, vectical, calcijex] or paricalcitol [zemplar]). consume supplements with more than 1200 mg calcium per day. known diagnosis of hypercalcemia or a condition associated with vitamin d hypersensitivity. prior diagnosis of cancer *and* currently undergoing radiation, chemotherapy, or immunotherapy. kidney failure or dialysis; severe liver disease or cirrhosis. any parathyroid conditions. use of medications for seizures or epilepsy. examples: carbamazepine (carbatrol, tegretol), phenytoin (dilantin, phenytek), valproic acid (depakene), oxcarbazepine (oxtellar, trileptal), phenobarbital, topiramate (topamax). use of digoxin. inability to receive an overnight express mail shipment of study pills at a home address. participation in other covid-19 trials. inclusion/exclusion criteria for household contacts: inclusion criteria: persons aged 18 years or older who live in the same household with an index individual and have been identified as the closest household contact within the same household (limited to 1 per household). persons aged 18 years or older who live in household with someone who tested positive for covid-19 within past 7 days but not participating in vivid. ability and willingness to understand and provide informed consent. |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
known current pregnancy. history of sars-cov-2 infection. receipt of a sars-cov-2 vaccination or monoclonal antibody. unable to complete online questionnaires or adhere to study requirements. consume more than 1000 iu per day of vitamin d from all supplemental sources combined (individual vitamin d supplements, calcium plus vitamin d supplements, medications with vitamin d [e.g., fosamax plus d], and multivitamins) in the past 4 weeks. use of prescription vitamin d treatments (calcitriol [rocaltrol, calcitrol, vectical, calcijex] or paricalcitol [zemplar]). consume supplements with more than 1200 mg calcium per day. known diagnosis of hypercalcemia or a condition associated with vitamin d hypersensitivity. prior diagnosis of cancer *and* currently undergoing radiation, chemotherapy, or immunotherapy. kidney failure or dialysis; severe liver disease or cirrhosis. any parathyroid condition. use of medications for seizures or epilepsy. examples: carbamazepine (carbatrol, tegretol), phenytoin (dilantin, phenytek), valproic acid (depakene), oxcarbazepine (oxtellar, trileptal), phenobarbital, topiramate (topamax). use of digoxin. inability to receive an overnight express mail shipment of study pills at a home address. participation in other covid-19 trials. |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Brigham and Women's Hospital |
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Inclusion age min
Last imported at : April 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
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Total sample size
Last imported at : July 13, 2022, 2 a.m. Source : ClinicalTrials.gov |
2024 |
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primary outcome
Last imported at : April 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Rate of seeking healthcare visits (including hospitalizations, emergency room visits, or ambulatory or virtual clinician visits) for symptoms or concerns related to COVID-19 or deaths in participants newly diagnosed with COVID-19 (index cases) |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1370, "treatment_name": "Vitamin d", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1370, "treatment_name": "Vitamin d", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |