The effect of supplementation with vitamins A, B, C, D, and E on disease severity and inflammatory responses in patients with COVID-19: a randomized clinical trial
et al., Trials, doi:10.1186/s13063-021-05795-4, IRCT20200319046819N1
, The effect of supplementation with vitamins A, B, C, D, and E on disease severity and inflammatory responses.., Trials, doi:10.1186/s13063-021-05795-4, IRCT20200319046819N1
Small RCT 60 ICU patients in Iran, 30 treated with vitamins A, B, C, D, and E, showing significant improvement in SOFA score and several inflammatory markers at day 7 with treatment.5,000 IU vitamin A daily, 600,000 IU vitamin D once, 300 IU of vitamin E twice a day, 500 mg vitamin C four times a day, and one ampule daily of B vitamins [thiamine nitrate 3.1 mg, sodium riboflavin phosphate 4.9 mg (corresponding to vitamin B2 3.6 mg), nicotinamide 40 mg, pyridoxine hydrochloride 4.9 mg (corresponding to vitamin B6 4.0 mg), sodium pantothenate 16.5 mg (corresponding to pantothenic acid 15 mg), sodium ascorbate 113 mg (corresponding to vitamin C 100 mg), biotin 60 μg, folic acid 400 μg, and cyanocobalamin 5 μg]. [irct.ir].
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risk of death, 88.9% lower, RR 0.11, p = 0.11, treatment 0 of 30 (0.0%), control 4 of 30 (13.3%), NNT 7.5, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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risk of hospitalization >7 days, 41.0% lower, RR 0.59, p = 0.25, treatment 4 of 30 (13.3%), control 16 of 30 (53.3%), NNT 2.5, adjusted per study, odds ratio converted to relative risk.
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relative SOFA score @day 7, 45.5% better, RR 0.55, p < 0.001, treatment 30, control 30.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Beigmohammadi et al., 14 Nov 2021, Single Blind Randomized Controlled Trial, Iran, peer-reviewed, 6 authors, study period April 2020 - July 2020, this trial uses multiple treatments in the treatment arm (combined with vitamins B, C, D, E) - results of individual treatments may vary, trial IRCT20200319046819N1.
Contact:
bitarafans@gmail.com.
The effect of supplementation with vitamins A, B, C, D, and E on disease severity and inflammatory responses in patients with COVID-19: a randomized clinical trial
Trials, doi:10.1186/s13063-021-05795-4
Background and objective: Because of the effect of vitamins on modulating the immune system function, we have evaluated the effect of supplementation with vitamins A, B, C, D, and E in ICU-admitted patients with COVID-19. Methods: This study was a randomized and single-blinded clinical trial in which 60 subjects were randomly assigned to two groups. The intervention group (n=30) received vitamins, and the control group did not receive any vitamin or placebo. The intervention was included 25,000 IU daily of vitamins A, 600,000 IU once during the study of D, 300 IU twice daily of E, 500 mg four times daily of C, and one amp daily of B complex for 7 days. At baseline and after the 7-day intervention, the serum levels of inflammatory markers, vitamins, and the SOFA score were assessed. In addition, the mortality rate and duration of hospitalization were evaluated after the intervention (IRCT registration number: IRCT20200319046819N1/registration date: 2020-04-04, https://www.irct.ir/trial/46838). Results: Significant changes were detected in serum levels of vitamins (p < 0.001 for all vitamins), ESR (p < 0.001), CRP (p = 0.001), IL6 (p = 0.003), TNF-a (p = 0.001), and SOFA score (p < 0.001) after intervention compared with the control group. The effect of vitamins on the mortality rate was not statistically significant (p=0.112). The prolonged hospitalization rate to more than 7 days was significantly lower in the intervention group than the control group (p=0.001). Regarding the effect size, there was a significant and inverse association between receiving the intervention and prolonged hospitalization (OR = 0.135, 95% CI 0.038-0.481; p=0.002); however, after adjusting for confounders, it was not significant (OR=0.402, 95% CI 0.086-1.883; p=0.247).
Authors' contributions The authors are required to identify their contributions to the work described in the manuscript in the author page. SB presented the conception and design of the study, with contributions from MTB. LA and AH collected the data. AA managed and supervised the laboratory tests. DS and SB analyzed and interpreted the data. DS wrote the first draft. SB edited the manuscript. All authors reviewed the first draft and commented on that. MTB generated the random allocation sequence, enrolled participants, and assigned participants to interventions. The authors read and approved the final manuscript.
Declarations Ethics approval and consent to participate The project has been approved by the ethical committee with the code of IR.TUMS.VCR.REC.1399.090 in Iran.
Competing interests The authors declare that they have no competing interests.
Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Late treatment
is less effective
is less effective
beigmohammadi2
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