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0 0.5 1 1.5 2+ Hospitalization, G1 vs. G2 -74% Improvement Relative Risk Case, G1 vs. G2 79% Case, G1 vs. G2 (b) 59% Case, G1 vs. G2 (c) 79% ICU admission, G3 vs. G4 57% Hospitalization, G3 vs. G4 -350% Case, G3 vs. G4 -15% Case, G3 vs. G4 (b) 32% Case, G3 vs. G4 (c) 22% Romero-Ibarguengoitia et al. NCT04810949 Vitamin D RCT Prophylaxis Is prophylaxis with vitamin D beneficial for COVID-19? RCT 112 patients in Mexico (May - August 2020) Trial compares with diet/sun, results vs. placebo may differ Fewer cases with vitamin D (p=0.008) Romero-Ibarguengoitia et al., medRxiv, doi:10.1101/2022.07.12.22277450 Favors vitamin D Favors diet/sun
Effect of Vitamin D3 supplementation vs. dietary-hygienic measures on SARS-COV-2 infection rates in hospital workers with 25-hydroxyvitamin D3 [25(OH)D3] levels >20 ng/mL
Romero-Ibarguengoitia et al., medRxiv, doi:10.1101/2022.07.12.22277450 (Preprint), NCT04810949 (history)
Romero-Ibarguengoitia et al., Effect of Vitamin D3 supplementation vs. dietary-hygienic measures on SARS-COV-2 infection rates in hospital.., medRxiv, doi:10.1101/2022.07.12.22277450 (Preprint), NCT04810949
Jul 2022   Source   PDF  
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RCT healthcare workers with vitamin D levels between 20-100 ng/mL, 43 treated with vitamin D 52,000 IU monthly, and 42 with dietary-hygienic measures, which were also focused on increasing vitamin D, including sun exposure for at least 10 minutes per day between 10:00-18:00, and consuming foods rich in vitamin D. There was significantly lower risk of COVID-19 with supplementation vs. diet/sun. Authors also report on patients with levels <20 ng/mL where treatment was recommended for all patients, however many patients declined treatment. In these non-randomized patients, lower risk was seen at 4 months with vitamin D supplementation, however there was no significant difference at 6 months.
Interpretation of the results is difficult because all groups had intervention aimed at increasing vitamin D. Supplemented patients showed greater improvement in levels, however dietary/sun patients could have a therapeutic advantage due to regular versus monthly consumption, and due to other benefits of the dietary/sun intervention. Authors indicate they asked patients monthly about consumption of food with vitamin D, however no results are provided.
risk of hospitalization, 73.7% higher, RR 1.74, p = 1.00, treatment 2 of 38 (5.3%), control 1 of 33 (3.0%), G1 vs. G2.
risk of case, 79.0% lower, HR 0.21, p = 0.008, treatment 5 of 38 (13.2%), control 13 of 33 (39.4%), NNT 3.8, 6 months, Cox proportional hazards, G1 vs. G2.
risk of case, 59.1% lower, RR 0.41, p = 0.04, treatment 6 of 43 (14.0%), control 14 of 41 (34.1%), NNT 5.0, 4 months, G1 vs. G2.
risk of case, 79.1% lower, RR 0.21, p = 0.003, treatment 3 of 43 (7.0%), control 14 of 42 (33.3%), NNT 3.8, 3 months, G1 vs. G2.
risk of ICU admission, 57.1% lower, RR 0.43, p = 1.00, treatment 0 of 24 (0.0%), control 1 of 72 (1.4%), NNT 72, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), G3 vs. G4.
risk of hospitalization, 350.0% higher, RR 4.50, p = 0.10, treatment 3 of 24 (12.5%), control 2 of 72 (2.8%), G3 vs. G4.
risk of case, 15.0% higher, HR 1.15, p = 0.72, treatment 9 of 24 (37.5%), control 29 of 72 (40.3%), 6 months, Cox proportional hazards, G3 vs. G4.
risk of case, 32.1% lower, RR 0.68, p = 0.35, treatment 7 of 27 (25.9%), control 29 of 76 (38.2%), NNT 8.2, 4 months, G3 vs. G4.
risk of case, 22.2% lower, RR 0.78, p = 0.64, treatment 7 of 28 (25.0%), control 27 of 84 (32.1%), NNT 14, 3 months, G3 vs. G4.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Romero-Ibarguengoitia et al., 15 Jul 2022, Randomized Controlled Trial, Mexico, preprint, mean age 44.4, 5 authors, study period May 2020 - August 2020, dosage 52,000IU single dose, monthly, this trial compares with another treatment - results may be better when compared to placebo, trial NCT04810949 (history).
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Effect of Vitamin D3 supplementation vs. dietary-hygienic measures on SARS-COV-2 infection rates in hospital workers with 25-hydroxyvitamin D3 [25(OH)D3] levels ≥20 ng/mL
Maria Elena Romero-Ibarguengoitia, Dalia Gutiérrez-González, Carlos Cantú-López, Miguel Angel Sanz-Sánchez, Arnulfo González-Cantú
Background. There is scant information on the effect of supplementation with vitamin D 3 in SARS-COV-2 infection cases when patient D3] levels are between 20-100ng/mL. Our aim was to evaluate the effect of supplementation with vitamin D 3 vs. dietary-hygienic measures on the SARS-COV-2 infection rate in participants with serum 25(OH)D 3 levels >20ng/mL. Methods. We invited hospital workers with 25(OH)D 3 levels between 20-100 ng/mL and no previous SARS-COV-2 infection; they were randomized as follows: treatment options were a) vitamin D 3 supplementation (52,000 IU monthly, G1) or b) dietary-hygienic measures (G2). We conducted a 3-to 6-month follow-up of SARS-COV-2 infections. Participants with 25(OH)D 3 levels <20 ng/mL were also analyzed. We divided these latter participants depending on whether they were supplemented (G3) or not (G4). Results. We analyzed 198 participants, with an average age of 44.4 (SD 9) years, and 130 (65.7%) were women. G1 had less cases of SARS-COV-2 infection than G2 after a follow-up of 3-to 6months (p<0.05). There were no differences between G3 and G4 at the 3-and 6-month follow-up cutoff points (p>0.05). Using mixed effect Cox regression analysis in 164 participants that completed six months of follow-up, vitamin D 3 supplementation appeared to act as a protective factor against SARS-COV-2 infection (HR 0.21, p=0.008) in G1 and G2. None of the participants treated with the supplementation doses had serum 25(OH)D 3 levels > 100ng/mL. Conclusion. Vitamin D 3 supplementation in participants with 25(OH)D 3 levels between 20-100 ng/mL have a lower rate of SARS-COV-2 infection in comparison with the use of dietaryhygienic measures at six months follow-up.
Competing interests: The author(s) have no conflicts of interest to declare. Ethics Statement: This research project was approved by the local IRB of the Universidad de Monterrey (Ref. 30062020-a-CN-CI ). An informed consent form was obtained from each participant. . Disclosure The authors have no potential conflicts of interest associated with this study. Author Approval: all authors read an approved the final version of the manuscript. Protocol access: This study protocol can be reviewed in supplementation; G2: 25(OH)D3 >20 ng/mL without supplementation; G3: 25(OH)D3 <20 ng/mL with supplementation; G4 25(OH)D3 <20 ng/mL without supplementation.
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