Effect of a Single High Dose of Vitamin D3 on Hospital Length of Stay in Patients With Moderate to Severe COVID-19: A Randomized Clinical Trial
Murai et al.,
Effect of a Single High Dose of Vitamin D3 on Hospital Length of Stay in Patients With Moderate to Severe..,
JAMA, doi:10.1001/jama.2020.26848 (date from earlier preprint), NCT04449718
Very late stage (mean 10 days from symptom onset, 90% on oxygen at baseline) vitamin D supplementation RCT not showing significant differences.
Ethnicity was poorly matched between arms, and diabetes was 41% in the treatment arm vs. 29% in the control arm. Baseline ventilation was 15% in the treatment arm vs. 12% control. Calcifediol or calcitriol, which avoids several days delay in conversion, may be more successful, especially with this very late stage usage. Treatment was dissolved in 10mL of peanut oil.
This study is excluded in the after exclusion results of meta
analysis:
very late stage, >50% on oxygen/ventilation at baseline; very late stage study using cholecalciferol instead of calcifediol or calcitriol.
risk of death, 48.7% higher, RR 1.49, p = 0.43, treatment 9 of 119 (7.6%), control 6 of 118 (5.1%).
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risk of mechanical ventilation, 47.5% lower, RR 0.52, p = 0.09, treatment 9 of 119 (7.6%), control 17 of 118 (14.4%), NNT 15.
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risk of ICU admission, 24.6% lower, RR 0.75, p = 0.30, treatment 19 of 119 (16.0%), control 25 of 118 (21.2%), NNT 19.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Murai et al., 17 Nov 2020, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 17 authors, average treatment delay 10.2 days, dosage 200,000IU single dose, trial
NCT04449718 (history).
Abstract: Research
JAMA | Original Investigation
Effect of a Single High Dose of Vitamin D3 on Hospital Length of Stay
in Patients With Moderate to Severe COVID-19
A Randomized Clinical Trial
Igor H. Murai, PhD; Alan L. Fernandes, PhD; Lucas P. Sales, MSc; Ana J. Pinto, BSc; Karla F. Goessler, PhD;
Camila S. C. Duran, MD; Carla B. R. Silva, MD; André S. Franco, MD; Marina B. Macedo, MD, MSc;
Henrique H. H. Dalmolin, MD; Janaina Baggio, MD; Guilherme G. M. Balbi, MD; Bruna Z. Reis, PhD;
Leila Antonangelo, MD, PhD; Valeria F. Caparbo, PhD; Bruno Gualano, PhD; Rosa M. R. Pereira, MD, PhD
Editorial page 1047
IMPORTANCE The efficacy of vitamin D3 supplementation in coronavirus disease 2019
(COVID-19) remains unclear.
Supplemental content
OBJECTIVE To investigate the effect of a single high dose of vitamin D3 on hospital length of
stay in patients with COVID-19.
DESIGN, SETTING, AND PARTICIPANTS This was a multicenter, double-blind, randomized,
placebo-controlled trial conducted in 2 sites in Sao Paulo, Brazil. The study included 240
hospitalized patients with COVID-19 who were moderately to severely ill at the time
of enrollment from June 2, 2020, to August 27, 2020. The final follow-up was on
October 7, 2020.
INTERVENTIONS Patients were randomly assigned to receive a single oral dose of 200 000 IU
of vitamin D3 (n = 120) or placebo (n = 120).
MAIN OUTCOMES AND MEASURES The primary outcome was length of stay, defined as the
time from the date of randomization to hospital discharge. Prespecified secondary outcomes
included mortality during hospitalization; the number of patients admitted to the intensive
care unit; the number of patients who required mechanical ventilation and the duration of
mechanical ventilation; and serum levels of 25-hydroxyvitamin D, total calcium, creatinine,
and C-reactive protein.
RESULTS Of 240 randomized patients, 237 were included in the primary analysis (mean [SD]
age, 56.2 [14.4] years; 104 [43.9%] women; mean [SD] baseline 25-hydroxyvitamin D level,
20.9 [9.2] ng/mL). Median (interquartile range) length of stay was not significantly different
between the vitamin D3 (7.0 [4.0-10.0] days) and placebo groups (7.0 [5.0-13.0] days)
(log-rank P = .59; unadjusted hazard ratio for hospital discharge, 1.07 [95% CI, 0.82-1.39];
P = .62). The difference between the vitamin D3 group and the placebo group was not
significant for in-hospital mortality (7.6% vs 5.1%; difference, 2.5% [95% CI, –4.1% to 9.2%];
P = .43), admission to the intensive care unit (16.0% vs 21.2%; difference, –5.2% [95% CI,
–15.1% to 4.7%]; P = .30), or need for mechanical ventilation (7.6% vs 14.4%; difference,
–6.8% [95% CI, –15.1% to 1.2%]; P = .09). Mean serum levels of 25-hydroxyvitamin D
significantly increased after a single dose of vitamin D3 vs placebo (44.4 ng/mL vs 19.8
ng/mL; difference, 24.1 ng/mL [95% CI, 19.5-28.7]; P < .001). There were no adverse events,
but an episode of vomiting was associated with the intervention.
CONCLUSIONS AND RELEVANCE Among hospitalized patients with COVID-19, a single high dose
of vitamin D3, compared with placebo, did not significantly reduce hospital length of stay. The
findings do not support the use of a high dose of vitamin D3 for treatment of moderate to
severe COVID-19.
TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04449718
Author Affiliations: Author
affiliations are listed at the end of this
article.
JAMA. 2021;325(11):1053-1060. doi:10.1001/jama.2020.26848
Published online February 17,..
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