Browsing by Author "Iturriaga Ortiz, Carolina Alejandra"

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    Effect of weekly vitamin D supplementation on the severity of atopic dermatitis and type 2 immunity biomarkers in children: A randomized controlled trial
    (2024) Borzutzky Schachter, Arturo José; Iturriaga Ortiz, Carolina Alejandra; Pérez Mateluna, Guillermo Andres; Cristi, Francisca; Cifuentes Aguila, Lorena Isabel; Silva‐Valenzuela, Sergio; Vera Kellet, Cristian Andres; Cabalín Arenas, Carolina Andrea; Hoyos Bachiloglu, Rodrigo Andres; Navarrete Dechent, Cristian Patricio; Cossio Traverso, Maria Laura; Le Roy, Catalina; Camargo, Jr, Carlos A.
    Background: Vitamin D (VD) deficiency is common among patients with atopic dermatitis (AD) and often associated with severity. However, randomized trials of VD supplementation in AD have had equivocal results, and there is little information regarding the effect of VD supplementation on type 2 immunity in AD patients.Objectives: To investigate the efficacy of VD supplementation to decrease severity of AD and to alter type 2 immunity biomarkers.Methods: We performed a randomized, double-blind, placebo-controlled trial. We randomly assigned 101 children with AD to weekly oral vitamin D3 (VD3) or placebo for 6 weeks. The primary outcome was the change in the Severity Scoring of AD (SCORAD).Results: Mean age of subjects was 6.3 ± 4.0 years, and baseline SCORAD was 32 ± 29. At baseline, 57% of children were VD deficient, with no difference between groups. Change in 25(OH)D was significantly greater with VD3 than placebo (+43.4 ± 34.5 nmol/L vs. +2.3 ± 21.2 nmol/L, p < 0.001). SCORAD change at 6 weeks was not different between VD and placebo (-5.3 ± 11.6 vs. -5.5 ± 9.9, p = 0.91). There were no significant between-group differences in change of eosinophil counts, total IgE, Staphylococcal enterotoxin specific IgE, CCL17, CCL22, CCL27, LL-37 or Staphylococcus aureus lesional skin colonization. Vitamin D receptor (VDR) gene single nucleotide polymorphisms FokI, ApaI and TaqI did not modify subjects' response to VD supplementation.Conclusions: Among children with AD, weekly VD supplementation improved VD status but did not modify AD severity or type 2 immunity biomarkers compared to placebo (ClinicalTrials.gov NCT01996423).
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    Interferon β-1a ring prophylaxis to reduce household transmission of SARS-CoV-2: a cluster randomised clinical trial
    (Elsevier Ltd, 2023) Castro Rodríguez, José Antonio; Fish, Eleanor; Montgomery, Samuel T.; Kollmann, Tobias R.; Iturriaga Ortiz, Carolina Alejandra; Shannon, Casey; Karpievitch, Yuliya; Ho, Joseph; Chen, Virginia; Balshaw, Robert; Ben-Othman, Rym; Aniba, Radhouane; Gidi Yunge, Francisca Andrea; Hartnell, Lucy; Hancock, David G.; Perez Mateluna, Guillermo Andrés; Urzua, Marcela; Tebbutt, Scott J.; Garcia-Huidobro, Munita Diego Nicolas; Perret, Perez Cecilia; Borzutzky Schachter, Arturo José; Stick, Stephen M.
    © 2023 The Author(s)Background: Accumulating evidence indicates that an early, robust type 1 interferon (IFN) response to SARS-CoV-2 is important in determining COVID-19 outcomes, with an inadequate IFN response associated with disease severity. Our objective was to examine the prophylactic potential of IFN administration to limit viral transmission. Methods: A cluster randomised open label clinical trial was undertaken to determine the effects of pegylated IFNβ-1a administration on SARS-CoV-2 household transmission between December 3rd, 2020 and June 29th, 2021. Index cases were identified from databases of confirmed SARS-CoV-2 individuals in Santiago, Chile. Households were cluster randomised (stratified by household size and age of index cases) to receive 3 doses of 125 μg subcutaneous pegylated IFNβ-1a (172 households, 607 participants), or standard care (169 households, 565 participants). The statistical team was blinded to treatment assignment until the analysis plan was finalised. Analyses were undertaken to determine effects of treatment on viral shedding and viral transmission. Safety analyses included incidence and severity of adverse events in all treatment eligible participants in the standard care arm, or in the treatment arm with at least one dose administered. Clinicaltrials.gov identifier: NCT04552379. Findings: 5154 index cases were assessed for eligibility, 1372 index cases invited to participate, and 341 index cases and their household contacts (n = 831) enrolled. 1172 participants in 341 households underwent randomisation, with 607 assigned to receive IFNβ-1a and 565 to standard care. Based on intention to treat (ITT) and per protocol (PP) analyses for the primary endpoints, IFNβ-1a treatment did not affect duration of viral shedding in index cases (absolute risk reduction = −0.2%, 95% CI = −8.46% to 8.06%) and transmission of SARS-CoV-2 to household contacts (absolute risk reduction = 3.87%, 95% CI = −3.6% to 11.3%). Treatment with IFNβ-1a resulted in significantly more treatment-related adverse events, but no increase in overall adverse events or serious adverse events. Interpretation: Based upon the primary analyses, IFNβ-1a treatment did not affect duration of viral shedding or the probability of SARS-CoV-2 transmission to uninfected contacts within a household. Funding: Biogen PTY Ltd. Supply of interferon as ‘Plegridy (peginterferon beta-1a).’ The study was substantially funded by BHP Holdings Pty Ltd.
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    Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial
    Abarca Villaseca, Katia; Iturriaga Ortiz, Carolina Alejandra; Urzua, Marcela; Le Corre Perez, Monique Nicole; Pineda Núñez, Augusto Naim; Fernandez Anwandter, Carolina; Domínguez De Landa, María Angelica; González Carbonell, Pablo Andrés; Bueno, Susan M.; Donato, Paulina; Espinoza, Pilar; Fuentes, Daniela; Gonzalez, Marcela; Guzman, Paula; Munoz-Venturelli, Paula; Perez, Carlos M.; Potin, Marcela; Rojas, Alvaro; Gonzalez-Aramundiz, Jose, V; Galvez, Nicolas M. S.; Aguirre-Boza, Francisca; Aljaro, Sofia; Federico Batiz, Luis; Campisto, Yessica; Cepeda, Mariela; Cortes, Aaron; Lopez, Sofia; Loreto Perez, Maria; Schilling, Andrea; Kalergis, Alexis M.
    Several vaccines have been developed to control the COVID-19 pandemic. CoronaVac (R), an inactivated SARS-CoV-2 vaccine, has demonstrated safety and immunogenicity, preventing severe COVID-19 cases. We investigate the safety and non-inferiority of two immunization schedules of CoronaVac (R) in a non-inferiority trial in healthy adults. A total of 2302 healthy adults were enrolled at 8 centers in Chile and randomly assigned to two vaccination schedules, receiving two doses with either 14 or 28 days between each. The primary safety and efficacy endpoints were solicited adverse events (AEs) within 7 days of each dose, and comparing the number of cases of SARS-CoV-2 infection 14 days after the second dose between the schedules, respectively. The most frequent local AE was pain at the injection site, which was less frequent in participants aged >= 60 years. Other local AEs were reported in less than 5% of participants. The most frequent systemic AEs were headache, fatigue, and myalgia. Most AEs were mild and transient. There were no significant differences for local and systemic AEs between schedules. A total of 58 COVID-19 cases were confirmed, and all but 2 of them were mild. No differences were observed in the proportion of COVID-19 cases between schedules. CoronaVac (R) is safe, especially in >= 60-year-old participants. Both schedules protected against COVID-19 hospitalization.