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All Studies   Meta Analysis    Recent:   

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

Sarhan et al., Medicina, doi:10.3390/medicina58101358, NCT04738760
Sep 2022  
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Mortality 19% Improvement Relative Risk Improvement 74% Time to improvement 29% Hospitalization time 31% Vitamin D  Sarhan et al.  LATE TREATMENT  RCT Is late treatment with vitamin D beneficial for COVID-19? RCT 116 patients in Egypt (December 2020 - June 2021) Lower mortality (p=0.003) and greater improvement (p=0.03) c19early.org Sarhan et al., Medicina, September 2022 Favorshigh dose Favorslow dose 0 0.5 1 1.5 2+
Vitamin D for COVID-19
8th treatment shown to reduce risk in October 2020
 
*, now with p < 0.00000000001 from 122 studies, recognized in 9 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 77 treatments. c19early.org
RCT comparing 200,000IU IM cholecalciferol and 1mcg/day alfacalcidol, showing lower mortality and improved recovery with high dose treatment.
Cholecalciferol was used in this study. Meta analysis shows that late stage treatment with calcitriol / calcifediol (or paricalcitol, alfacalcidol, etc.) is more effective than cholecalciferol: 69% [47‑82%] lower risk vs. 39% [27‑49%] lower risk. Cholecalciferol requires two hydroxylation steps to become activated - first in the liver to calcifediol, then in the kidney to calcitriol. Calcitriol, paricalcitol, and alfacalcidol are active vitamin D analogs that do not require conversion. This allows them to have more rapid onset of action compared to cholecalciferol. The time delay for cholecalciferol to increase serum calcifediol levels can be 2-3 days, and the delay for converting calcifediol to active calcitriol can be up to 7 days.
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). Contact: gomaa@ju.edu.sa (corresponding author).
This PaperVitamin DAll
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, Ahmed E Abou Warda, Rania M Sarhan, Marian S Boshra, Gomaa Mostafa-Hedeab, Bashayer F Alruwaili, Haytham Soliman Ghareeb Ibrahim, Mona F Schaalan, Shaimaa Fathy
Medicina, doi:10.3390/medicina58101358
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 COVID-19 patients and was associated with better clinical improvement and fewer adverse outcomes compared to low-dose vitamin D.
Predictors of Clinical Improvement by Binary Logistic Regression Analysis The binary logistic regression analysis indicated that better clinical improvement and less severe COVID-19 symptoms were associated with the need for low oxygen (OR = 6.67, C.I. = 2.07-21.35, p = 0.001) and inversely associated with the need for high oxygen and NIMV (OR = 6.19, C.I. = 0.41-0.86, p = 0.031), the need for an invasive mechanical ventilator (MV) (OR = 0.83, C.I. = 0.64-0.98, p = 0.012), diabetes (OR = 0.37, C.I. = 0.33-0.56, p = 0.045), atrial fibrillation (OR = 0.41, C.I.= 0.15-0.38, p = 0.008), and the occurrence of secondary infection (OR = 0.33, C.I. = 0.16-0.94, p = 0.004), as shown in Table 3 . However, after conducting a multiple logistic regression with covariates reporting a p-value less than 0.2 in the univariate regression analysis, only the need for low oxygen (adjusted OR = 5.53, C.I. = 2.41-15.12, p = 0.005), the need for high oxygen/NIMV (adjusted OR = 0.23, C.I. = 0.31-0.78, p = 0.041), the need for invasive MV (adjusted OR= 0.71, C.I. = 0.58-0.81, p = 0.038), diabetes (adjusted OR = 0.42, C.I. = 0.28-0.74, p = 0.048), and the occurrence of secondary bacterial infection (adjusted OR = 0.46, C.I.= 0.31-0.83, p = 0.02) remained significant, as shown in Table 4 . Predictors of Mortality by Binary Logistic Regression Analysis The binary logistic regression analysis revealed that COVID-19 mortality was associated with the need for MV (OR = 4.93, C.I. = 1.1-12.56, p = 0.039),..
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Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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