scholarly journals Pilot trial of high-dose vitamin C in critically ill COVID-19 patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Jing Zhang ◽  
Xin Rao ◽  
Yiming Li ◽  
Yuan Zhu ◽  
Fang Liu ◽  
...  

Abstract Background Few specific medications have been proven effective for the treatment of patients with severe coronavirus disease 2019 (COVID-19). Here, we tested whether high-dose vitamin C infusion was effective for severe COVID-19. Methods This randomized, controlled, clinical trial was performed at 3 hospitals in Hubei, China. Patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the ICU were randomly assigned in as 1:1 ratio to either the high-dose intravenous vitamin C (HDIVC) or the placebo. HDIVC group received 12 g of vitamin C/50 ml every 12 h for 7 days at a rate of 12 ml/hour, and the placebo group received bacteriostatic water for injection in the same way within 48 h of arrival to ICU. The primary outcome was invasive mechanical ventilation-free days in 28 days (IMVFD28). Secondary outcomes were 28-day mortality, organ failure (Sequential Organ Failure Assessment (SOFA) score), and inflammation progression (interleukin-6). Results Only 56 critical COVID-19 patients were ultimately recruited due to the early control of the outbreak. There was no difference in IMVFD28 between two groups (26.0 [9.0–28.0] in HDIVC vs 22.0 [8.50–28.0] in control, p = 0.57). HDIVC failed to reduce 28-day mortality (P = 0.27). During the 7-day treatment period, patients in the HDIVC group had a steady rise in the PaO2/FiO2 (day 7: 229 vs. 151 mmHg, 95% CI 33 to 122, P = 0.01), which was not observed in the control group. IL-6 in the HDIVC group was lower than that in the control group (19.42 vs. 158.00; 95% CI -301.72 to -29.79; P = 0.04) on day 7. Conclusion This pilot trial showed that HDIVC failed to improve IMVFD28, but might show a potential signal of benefit in oxygenation for critically ill patients with COVID-19 improving PaO2/FiO2 even though.

Author(s):  
Jing Zhang ◽  
Xin Rao ◽  
Yiming Li ◽  
Yuan Zhu ◽  
Fang Liu ◽  
...  

Abstract Background: No specific medication has been proven effective for the treatment of patients with severe coronavirus disease 2019 (COVID-19). Here, we tested whether high-dose vitamin C infusion was effective for severe COVID-19.Methods: This randomized, controlled, clinical trial was performed at 3 hospitals in Hubei, China. Patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the ICU were randomly assigned in as 1:1 ratio to either the high-dose intravenous vitamin C (HDIVC) or the placebo. HDIVC group received 12 g of vitamin C/50 ml every 12 hours for 7 days at a rate of 12 ml/hour, and the placebo group received bacteriostatic water for injection in the same way. The primary outcome was invasive mechanical ventilation-free days in 28 days(IMVFD28). Secondary outcomes were 28-day mortality, organ failure, and inflammation progression.Results: Only fifty-six critical COVID-19 patients were ultimately recruited due to the early control of the outbreak. There was no difference in IMVFD28 between two groups. During the 7-day treatment period, patients in the HDIVC group had a steady rise in the PaO2/FiO2 (day 7: 229 vs. 151 mmHg, 95% CI 33 to 122, P=0.01). Patients with SOFA scores ≥3 in the HDIVC group exhibited a trend of reduction in 28-day mortality (P=0.06) in univariate survival analysis. IL-6 in the HDIVC) group was lower than that in the placebo group (19.42 vs. 158.00; 95% CI -301.72 to -29.79; P=0.04) on day 7. Conclusion: This pilot trial showed that HDIVC might show a potential signal of benefit for critically ill patients with COVID-19, improving oxygenation even though it failed to improve IMVFD28. Clinicaltrial.gov identifer and date: NCT04264533. Registered February 14 2020.


Author(s):  
Jing Zhang ◽  
Xin Rao ◽  
Yiming Li ◽  
Yuan Zhu ◽  
Fang Liu ◽  
...  

Abstract BackgroundNo specific medication has been proven effective for the treatment of patients with severe coronavirus disease 2019 (COVID-19). Here, we tested whether high-dose vitamin C infusion was effective for severe COVID-19.MethodsThis randomized, controlled clinical trial was performed at 3 hospitals in Hubei, China. Patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the ICU were randomly assigned in as 1:1 ratio to either the high-dose intravenous vitamin C (HDIVC) or the placebo. HDIVC group received 12 g of vitamin C/50 ml every 12 hours for 7 days at a rate of 12 ml/hour, and the placebo group received bacteriostatic water for injection in the same way. The primary outcome was invasive mechanical ventilation-free days in 28 days(IMVFD28). Secondary outcomes were 28-day mortality, organ failure, and inflammation progression.ResultsFifty-four critical COVID-19 patients were ultimately recruited. There was no difference in IMVFD28 between two groups. During the 7-day treatment period, patients in the HDIVC group had a steady rise in the PaO2/FiO2 (day 7: 229 vs. 151 mmHg, 95% CI 33 to 122, P = 0.01). Patients with SOFA scores ≥ 3 in the HDIVC group exhibited a significant reduction in 28-day mortality (P = 0.05) in univariate survival analysis. IL-6 in the VC group was lower than that in the placebo group (19.42 vs. 158.00; 95% CI -301.72 to -29.79; P = 0.04) on day 7.ConclusionThe addition of HDIVC may provide a protective clinical effect without any adverse events in critically ill patients with COVID-19.Clinicaltrial.gov identifer: NCT04264533


Critical Care ◽  
2019 ◽  
Vol 23 (1) ◽  
Author(s):  
Mikio Nakajima ◽  
Morita Kojiro ◽  
Shotaro Aso ◽  
Hiroki Matsui ◽  
Kiyohide Fushimi ◽  
...  

Abstract Background Vitamin C is a well-documented antioxidant that reduces oxidative stress and fluid infusion in high doses; however, the association between high-dose vitamin C and reduced mortality remains unclear. This study evaluates the effect of high-dose vitamin C in severe burn patients under two varying thresholds. Methods We enrolled adult patients with severe burns (burn index ≥ 15) who were registered in the Japanese Diagnosis Procedure Combination national inpatient database from 2010 to 2016. Propensity score matching was performed between patients who received high-dose vitamin C within 1 day of admission (vitamin C group) and those who did not (control group). High-dose vitamin C was defined as a dosage in excess of 10 g or 24 g within 2 days of admission. The primary outcome was in-hospital mortality. Results Eligible patients (n = 2713) were categorized into the vitamin C group (n = 157) or control group (n = 2556). After 1:4 propensity score matching, we compared 157 and 628 patients who were administered high-dose vitamin C (> 10-g threshold) and controls, respectively. Under this particular threshold, high-dose vitamin C therapy was associated with reduced in-hospital mortality (risk ratio, 0.79; 95% confidence interval, 0.66–0.95; p = 0.006). In contrast, in-hospital mortality did not differ between the control and high-dose vitamin C group under the > 24-g threshold (risk ratio, 0.83; 95% confidence interval, 0.68–1.02; p = 0.068). Conclusions High-dose vitamin C therapy was associated with reduced mortality in patients with severe burns when used under a minimum threshold of 10 g within the first 2 days of admission. While “high-dose” vitamin C therapy lacks a universal definition, the present study reveals that different “high-dose” regimens may yield improved outcomes.


Author(s):  
Hasanali Karimpour ◽  
Alireza Bahrami ◽  
Shila Amini ◽  
Mansour Rezaei ◽  
Javad Amini-Saman ◽  
...  

Septic shock may occur in critically ill patients and despite antimicrobial treatment, it is associated with a high mortality rate. It is reasonable to look for new treatment modalities that might improve outcome. This is a randomized, double-blind control trial aiming at critically-ill septic patients in a tertiary hospital. Patients with quick sofa score of 2 and with organ dysfunction were included in this study. The intervention group received high doses of vitamin C at a dose of 50 mg/kg/four times daily along with thiamine at a dose of 200 mg/ twice daily) and the control group received normal saline for four days. The dose of vasopressors, procalcitonin and lactate clearance, and mean sequential organ failure assessment (SOFA) score were examined in the two groups. Patients were followed for 28 days. One hundred patients were allocated into two equal groups, and there was no difference between the two groups regarding baseline characteristics. Mean lactate concentration, SOFA score, days of antimicrobial therapy, and mortality at 28 days were similar between them. However, the mean procalcitonin concentration, and mean vasopressor treatment hours were significantly lower in the intervention group (p<0.05). Although Days of ICU stay were lower in the intervention group, It did not reach statistical significance. The results of this study showed that treatment with high dose vitamin C Reduces the vasopressor requirement without any effects on other parameters. Further studies with larger sample size are required for more generalizable results.


2021 ◽  
Author(s):  
Saeidreza JamaliMoghadamSiahkali ◽  
Besharat Zarezade ◽  
Sogol Koolaji ◽  
Seyed Ahmad Seyed Alinaghi ◽  
Abolfazl Zendehdel ◽  
...  

Abstract Background: To assess the effectiveness of vitamin C treatment against coronavirus disease 2019 (COVID-19)Methods: An open-label, randomized, and controlled trial was conducted on patients with severe COVID-19 infection. The case and control treatment groups each consisted of 30 patients. The control group received lopinavir/ritonavir and hydroxychloroquine and the case group received high-dose of vitamin C (six gr daily) added to the same regimen. Results: There were no statistically significant differences between two groups with respect to age and gender, laboratory results, and underlying diseases. On the 3rd day of hospitalization, the mean core body temperatures was significantly lower and SpO2 was higher In the case group (p value = 0.001, and 0.014, respectively). The median length of hospitalization in case group which was significantly longer than the control group (8.5 days vs. 6.5 days) (p value = 0.0280). There was no significant difference in SpO2 levels at discharge time, the length of ICU stay, and mortality between the two groups.Conclusions: We did not find significantly better outcomes in the group who were treated with high-dose vitamin C in addition to the main treatment regimen at discharge.Trial registration: The project was registered by Iranian Registry of Clinical Trials.IRCT20200411047025N1


2021 ◽  
Author(s):  
Bing Zhao ◽  
Mengjiao Li ◽  
Jian Li ◽  
Leshan Liu ◽  
Yihui Wang ◽  
...  

Abstract Sepsis is an inflammatory syndrome with life-threatening organ dysfunction resulting from a dysregulated host response to infection. Although the treatment for sepsis has improved a lot in the last 30 years, sepsis related mortality remains high. In the recent 10 years, high dose intravenous injection of vitamin C, the first line antioxidant of human, has received more and more attention in the field of critical care, its beneficial effect has been demonstrated by several small scale clinical trial and animal studies, but the effect of high dose vitamin C on sepsis in a larger trial seems warranted in further study. Here we will conduct a prospective, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial named as HDVCIS. The trial protocol has been approved by Clinical Trail Ethics Committee of Ruijin Hospital of Shanghai JiaoTong University School of Medicine. This trial has been registered in Chinese Clinical Trial Registry (ChiCTR1800017633) in August 7, 2018. Patients will be recruited from 4 medical centers in China. Its object is to testify the efficacy and safety of high dose vitamin C in the treatment of sepsis.


2017 ◽  
Vol 47 (1) ◽  
pp. 58
Author(s):  
Viika Miftakhul Umami ◽  
Suprihati Suprihati ◽  
Farokah Farokah

Latar belakang: Tonsilitis kronik menyebabkan terbentuknya oksidan, salah satunya peroksidasilipid. Vitamin C dosis tinggi pasca tonsilektomi sebagai antioksidan diduga dapat menurunkan kadarperoksidasi lipid dan mempercepat penyembuhan luka.Tujuan: Membuktikan pengaruh vitamin Cdosis tinggi dapat mempercepat penyembuhan luka dan menurunkan kadar peroksidasi lipid pascatonsilektomi.Metode: Penelitian dengan desain randomized controlled trial (RCT). Empat puluh subjekyang memenuhi kriteria inklusi dan eksklusi di klinik Telinga Hidung Tenggorok – Bedah Kepala LeherRumah Sakit Soeselo Slawi dibagi dua, yaitu kelompok yang mendapat vitamin C dosis tinggi segerapasca tonsilektomi dan terapi standar (amoksisilin dan parasetamol), kelompok kontrol ndapat terapistandar. Kadar peroksidasi lipid dievaluasi sebelum tonsilektomi dan 2 minggu pasca tonsilektomi. Derajatnyeri dinilai dengan visual analogue scale (VAS) atau wong baker faces pain rating scale (WBFPRS)dan derajat epitelisasi dinilai pada hari ke-1, 4, 7, dan 14 pasca tonsilektomi. Data dianalisis dengan ujit berpasangan, uji t tidak berpasangan, dan uji Mann-Whitney.Hasil: Empat puluh subjek dapat diikutisampai akhir penelitian. Vitamin C dosis tinggi dapat mengurangi derajat nyeri sejak hari keempatpasca tonsilektomi (p<0,05), dan mempercepat derajat epitelisasi sejak hari pertama pasca tonsilektomi(p<0,05), serta lebih banyak sembuh pada hari ke-14 pasca tonsilektomi (p=0,002). Peroksidasi lipidserum 2 minggu pasca tonsilektomi pada kelompok vitamin C dosis tinggi cenderung lebih banyak yangturun dibanding kelompok kontrol (p=0,057). Kesimpulan: Vitamin C dosis tinggi dapat mempercepatpenyembuhan luka dan menurunkan kadar peroksidasi lipid pasca tonsilektomi.Kata kunci : Vitamin C, peroksidasi lipid, penyembuhan luka, pasca tonsilektomi ABSTRACTBackground: Chronic tonsillitis results oxidation products, one of them is lipid peroxidation.High dose vitamin C post tonsillectomy as antioxidant estimated decrease lipid peroxidation level andaccelerate wound healing. Purpose: To investigate the effect of high dose vitamin C to accelerate woundhealing and decrease lipid peroxidation level in post tonsillectomy patients. Methods: A randomizedcontrolled trial design involved fourty subjects at ENT-HNS clinic of Soeselo Slawi Hospital. The subjectswere divided into the study group who received high dose vitamin C immediately after tonsillectomy andstandart treatment (amoxicillin and paracetamol), the control group who received standart treatment. Lipidperoxidation level was observed at pre and 2 weeks post tonsillectomy, while pain scale (VAS/WBFPRS)and wound epithelialization were observed at 1st, 4th, 7th, and 14th days post tonsillectomy. Data wereanalized with independent-sample t test, paired-sample t test, and Mann-Whitney test.Results: Fourtysubjects were followed until the study finished. High dose vitamin C decreased pain scale since 4 dayspost tonsillectomy (p<0,05), could accelerate wound epithelialization since first day post tonsillectomy(p<0,05), and the most patients recovered at 14th days post tonsillectomy (p=0,002). Lipid peroxidationlevel at 2 weeks post tonsillectomy in high dose vitamin C group tend to lower than the control group(p=0,057). Conclusion: High dose vitamin C post tonsillectomy can accelerate wound healing anddecrease lipid peroxidation level post tonsillectomy.Key words: Vitamin C, lipid peroxidation, wound healing, post tonsillectomy


Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1280
Author(s):  
Jan Mieszkowski ◽  
Andżelika Borkowska ◽  
Błażej Stankiewicz ◽  
Andrzej Kochanowicz ◽  
Bartłomiej Niespodziński ◽  
...  

Purpose: A growing number of studies indicate the importance of vitamin D supplementation for sports performance. However, the effects of a single high-dose vitamin D supplementation on ultramarathon-induced inflammation have not been investigated. We here analyzed the effect of a single high-dose vitamin D supplementation on the inflammatory marker levels in ultramarathon runners after an ultramarathon run (maximal run 240 km). Methods: In the study, 35 runners (amateurs) were assigned into two groups: single high-dose vitamin D supplementation group, administered vitamin D (150,000 IU) in vegetable oil 24 h before the start of the run (n = 16); and placebo group (n = 19). Blood was collected for analysis 24 h before, immediately after, and 24 h after the run. Results: Serum 25(OH)D levels were significantly increased after the ultramarathon in both groups. The increase was greater in the vitamin D group than in the control group. Based on post-hoc and other analyses, the increase in interleukin 6 and 10, and resistin levels immediately after the run was significantly higher in runners in the control group than that in those in the supplementation group. Leptin, oncostatin M, and metalloproteinase tissue inhibitor levels were significantly decreased in both groups after the run, regardless of the supplementation. Conclusions: Ultramarathon significantly increases the serum 25(OH)D levels. Attenuation of changes in interleukin levels upon vitamin D supplementation confirmed that vitamin D has anti-inflammatory effect on exercise-induced inflammation.


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