A Randomized Pilot Study Using Calcitriol in Hospitalized Patients
et al., Bone,
RCT 50 hospitalized patients in the USA, 25 treated with calcitriol, showing significantly improved oxygenation with treatment. Mortality, intubation, ICU admission, and hospitalization time also favored treatment, while not reaching statistical significance with the very small sample size.
risk of death, 85.7% lower, RR 0.14, p = 0.23, treatment 0 of 25 (0.0%), control 3 of 25 (12.0%), NNT 8.3, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of mechanical ventilation, 80.0% lower, RR 0.20, p = 0.48, treatment 0 of 25 (0.0%), control 2 of 25 (8.0%), NNT 12, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of ICU admission, 37.5% lower, RR 0.62, p = 0.33, treatment 5 of 25 (20.0%), control 8 of 25 (32.0%), NNT 8.3.
hospitalization time, 40.5% lower, relative time 0.60, p = 0.14, treatment 25, control 25.
relative Δ SaO2/FiO2, RR 0.14, p = 0.03, treatment 25, control 25, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Elamir et al., 8 Sep 2021, Randomized Controlled Trial, USA, peer-reviewed, 9 authors, dosage calcitriol 0.5μg days 1-14.
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A Randomized Pilot Study Using Calcitriol in Hospitalized
Yasmine M. Elamir, Hajira Amir, Steven Lim, Yesha Patel Rana,
Carolina Gonzalez Lopez, Natalia Viera Feliciano, Ali Omar,
William Paul Grist, Michael A. Via
To appear in:
12 June 2021
1 August 2021
3 September 2021
Please cite this article as: Y.M. Elamir, H. Amir, S. Lim, et al., A Randomized Pilot
Study Using Calcitriol in Hospitalized Patients, Bone (2021), https://doi.org/10.1016/
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To Whom It May Concern,
Thank you for considering our work for potential publication in the prestigious Bone Journal
Briefly: The systemic illness associated with SARS-CoV-2 infection results in hospitalization
rate of 380.3 hospitalizations per 100,000 population, overwhelming health care systems. Some
emerging therapies demonstrate modest benefits, but use is not feasible in large inpatient
numbers. Vitamin D regulates expression of approximately 11,000 genes spanning many
physiologic functions that include regulation of both innate and adaptive immune function. We
investigate the potential benefit of calcitriol therapy given to patients hospitalized with COVID19. This pilot study is an open label, 1:1 randomized clinical trial of calcitriol 0.5 mcg daily for
14 days or hospital discharge vs. no treatment given to hospitalized adult patients with COVID19.
We enrolled 50 consecutive patients, 25 per trial arm. The change in peripheral arterial oxygen
saturation to the inspired fraction of oxygen (SaO2/FIO2 ratio) on admission and discharge
between the groups the control group had an average increase of +13.2 (+/- 127.7) on discharge
and the calcitriol group had an increase of +91.04 (+/- 119.08) (p= .0305), suggesting an
improvement in oxygenation among subjects who received calcitriol. Additionally, 12 patients in
the control group required oxygen supplementation on admission and..
is less effective
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