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Table 1 Large-scale randomised clinical trials on vitamin D supplementation in hospitalised patients

From: Update on vitamin D role in severe infections and sepsis

Authors, year of publication

Study sites

Study duration

Number of patients

Inclusion criteria

Intervention

Primary outcome

Patients characteristics

Main result

Amrein et al. 2014 [26]

Single centre, Austria

2012–2015

475

Adult white critically ill patients, expected length of ICU stay ≥ 

48 h and with 25-hydroxyvitamin

D blood level of 20 ≤ ng/mL

Enteral vitamin D3 protocol administration: 540,000 IUs followed by monthly 90,000 IU for 5 months

Vs

Placebo

Length of hospital stay

Surgical patients were prevalent

Severe infections/sepsis: ~ 8% at admission

No difference for the primary outcome

Ginde et al. 2019 [27]

44 centres, USA

2017–2018

1078

Adult patients with with > 1 risk factors for death or lung injury, deemed to be managed in the ICU and with 25-hydroxyvitamin D blood level ≤ 20 ng/mL

Enteral vitamin D3 protocol administration: 540,000 IUs

Vs

Placebo

90-day mortality rate

Medical patients were prevalent

Severe infections/sepsis: ~ 33%

No difference for the primary outcome

Murai et al. 2021 [29]

2 centres, Brazil

2020

240

Adult patients with moderate to severe COVID-19

Oral vitamin D3 protocol administration: 200,000 IUs

Vs

Placebo

Length of hospital stay

Severe infections/sepsis: not declared

No difference for the primary outcome

Mariani et al. 2022 [90]

17 centres, Argentina

2020–2021

218

Adult patients admitted to general ward in the last 24 h with mild-to-moderate COVID-19 and risk factors for disease progression

Oral vitamin D3: 500,000 IUs

Vs

Placebo

Change in the respiratory SOFA between baseline and the highest rSOFA recorded up to day 7

Severe infections/sepsis: not declared

No difference for the primary outcome

  1. Abbreviations: SOFA Sepsis-related Organ Failure Assessment