Evidence for the Efficacy of a High Dose of Vitamin D on the Hyperinflammation State in Moderate-to-Severe COVID-19 Patients: A Randomized Clinical Trial
RCT comparing 200,000IU IM cholecalciferol and 1mcg/day alfacalcidol, showing lower mortality and improved recovery with high dose treatment.
risk of death, 18.5% lower, RR 0.81, p = 0.003, treatment 26 of 58 (44.8%), control 30 of 58 (51.7%), NNT 14, adjusted per study, odds ratio converted to relative risk, multivariable.
improvement, 74.4% better, OR 0.26, p = 0.03, treatment 58, control 58, adjusted per study, inverted to make OR<1 favor treatment, multivariable, RR approximated with OR.
time to improvement, 28.8% lower, relative time 0.71, p = 0.002, treatment 58, control 58.
hospitalization time, 31.5% lower, relative time 0.69, p = 0.04, treatment 58, control 58.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Sarhan et al., 27 Sep 2022, Randomized Controlled Trial, Egypt, peer-reviewed, 9 authors, study period December 2020 - June 2021, dosage 200,000IU single dose, trial NCT04738760 (history)
email@example.com (corresponding author).
Evidence for the Efficacy of a High Dose of Vitamin D on the
Hyperinflammation State in Moderate-to-Severe COVID-19
Patients: A Randomized Clinical Trial
Neven Sarhan 1 , Ahmed E. Abou Warda 2 , Rania M. Sarhan 3 , Marian S. Boshra 3 ,
Gomaa Mostafa-Hedeab 4, * , Bashayer F. ALruwaili 5 , Haytham Soliman Ghareeb Ibrahim 6 ,
Mona F. Schaalan 1 and Shaimaa Fathy 1
Citation: Sarhan, N.; Abou Warda,
A.E.; Sarhan, R.M.; Boshra, M.S.;
Mostafa-Hedeab, G.; ALruwaili, B.F.;
Ibrahim, H.S.G.; Schaalan, M.F.;
Fathy, S. Evidence for the Efficacy of
a High Dose of Vitamin D on the
Hyperinflammation State in
Patients: A Randomized Clinical
Trial. Medicina 2022, 58, 1358.
Academic Editor: Silvia Angeletti
Received: 14 September 2022
Accepted: 20 September 2022
Published: 27 September 2022
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with regard to jurisdictional claims in
Clinical Pharmacy Department, Faculty of Pharmacy, Misr International University, Cairo 11828, Egypt
Clinical Pharmacy Department, Faculty of Pharmacy, October 6 University, P.O. Box 12585, Giza 12585, Egypt
Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, P.O. Box 62514,
Beni-Suef 62511, Egypt
Pharmacology Department, Medical College, Jouf University, Sakaka 72388, Saudi Arabia
Community and Family Medicine Department, Division of Family Medicine, Medical College, Jouf University,
Sakaka 72388, Saudi Arabia
Cardiology Department, Faculty of Medicine, El-Fayoum University, P.O. Box 63514, El Fayoum 63511, Egypt
Correspondence: firstname.lastname@example.org; Tel.: +966-5346-2739
Abstract: Background and Objectives: Vitamin D supplementation plays a key effect in lowering
cytokine storms among COVID-19 patients by influencing the activity of the renin-angiotensin system
and the production of the angiotensin-2 converting enzyme. The study was conducted to explore
the effect of high-dose intramuscular vitamin D in hospitalized adults infected with moderate-tosevere SARS-CoV-2 in comparison with the standard of care in the COVID-19 protocol. Materials
and Methods: Two groups of patients were compared in this prospective randomized controlled trial
as the vitamin D was administered orally to group 1 (alfacalcidol 1 mcg/day) and intramuscularly
to group 2 (cholecalciferol 200,000 IU). One hundred and sixteen participants were recruited in
total, with fifty-eight patients in each group. Following the Egyptian Ministry of Health’s policy for
COVID-19 management, all patients received the same treatment for a minimum of five days. Results:
A significant difference was recorded in the length of hospital stay (8.6 versus 6.8 days), need for high
oxygen or non-invasive mechanical ventilator (67% versus 33%), need for a mechanical ventilator
(25% versus 75%), clinical improvement (45% versus 55%), the occurrence of sepsis (35% versus
65%), and in the monitored laboratory parameters in favor of high-dose vitamin D. Moreover, clinical
improvement was significantly associated with the need for low/high oxygen, an invasive/noninvasive mechanical ventilator (MV/NIMV), and diabetes, while mortality was associated with the
need for MV, ICU admission, atrial fibrillation, chronic obstructive pulmonary disease, asthma, and
the occurrence of secondary infection. Conclusions: Our study showed that high-dose vitamin D was
considered a promising treatment in the suppression of cytokine storms among..
is less effective
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