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10.1016/j.cct.2020.106176

http://scihub22266oqcxt.onion/10.1016/j.cct.2020.106176
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33045402!7547023!33045402
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suck abstract from ncbi


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pmid33045402      Contemp+Clin+Trials 2021 ; 100 (ä): 106176
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  • The vitamin D for COVID-19 (VIVID) trial: A pragmatic cluster-randomized design #MMPMID33045402
  • Wang R; DeGruttola V; Lei Q; Mayer KH; Redline S; Hazra A; Mora S; Willett WC; Ganmaa D; Manson JE
  • Contemp Clin Trials 2021[Jan]; 100 (ä): 106176 PMID33045402show ga
  • OBJECTIVES: To determine the effect of vitamin D supplementation on disease progression and post-exposure prophylaxis for COVID-19 infection. We hypothesize that high-dose vitamin D3 supplementation will reduce risk of hospitalization/death among those with recently diagnosed COVID-19 infection and will reduce risk of COVID-19 infection among their close household contacts. METHODS: We report the rationale and design of a planned pragmatic, cluster randomized, double-blinded trial (N = 2700 in total nationwide), with 1500 newly diagnosed individuals with COVID-19 infection, together with up to one close household contact each (~1200 contacts), randomized to either vitamin D3 (loading dose, then 3200 IU/day) or placebo in a 1:1 ratio and a household cluster design. The study duration is 4 weeks. The primary outcome for newly diagnosed individuals is the occurrence of hospitalization and/or mortality. Key secondary outcomes include symptom severity scores among cases and changes in the infection (seroconversion) status for their close household contacts. Changes in vitamin D 25(OH)D levels will be assessed and their relation to study outcomes will be explored. CONCLUSIONS: The proposed pragmatic trial will allow parallel testing of vitamin D3 supplementation for early treatment and post-exposure prophylaxis of COVID-19. The household cluster design provides a cost-efficient approach to testing an intervention for reducing rates of hospitalization and/or mortality in newly diagnosed cases and preventing infection among their close household contacts.
  • |*COVID-19 Drug Treatment[MESH]
  • |*Dietary Supplements[MESH]
  • |*Vitamin D/therapeutic use[MESH]
  • |Adult[MESH]
  • |COVID-19/mortality[MESH]
  • |Comorbidity[MESH]
  • |Double-Blind Method[MESH]
  • |Hospitalization/statistics & numerical data[MESH]
  • |Humans[MESH]
  • |Middle Aged[MESH]
  • |Minority Groups/statistics & numerical data[MESH]
  • |Pragmatic Clinical Trials as Topic[MESH]
  • |Risk Factors[MESH]
  • |SARS-CoV-2[MESH]
  • |Seroconversion[MESH]
  • |Severity of Illness Index[MESH]


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