ABSTRACT
BACKGROUND: Vitamin D deficiency (VDD) is highly prevalent in the pediatric intensive care unit (ICU) and associated with worse clinical course. Trials in adult ICU demonstrate rapid restoration of vitamin D status using an enteral loading dose is safe and may improve outcomes. There have been no published trials of rapid normalization of VDD in the pediatric ICU. METHODS: We conducted a multicenter placebo-controlled phase II pilot feasibility randomized clinical trial from 2016 to 2017. We randomized 67 critically ill children with VDD from ICUs in Canada, Chile and Austria using a 2:1 randomization ratio to receive a loading dose of enteral cholecalciferol (10,000 IU/kg, maximum of 400,000 IU) or placebo. Participants, care givers, and outcomes assessors were blinded. The primary objective was to determine whether the loading dose normalized vitamin D status (25(OH)D > 75 nmol/L). Secondary objectives were to evaluate for adverse events and assess the feasibility of a phase III trial. RESULTS: Of 67 randomized participants, one was withdrawn and seven received more than one dose of cholecalciferol before the protocol was amended to a single loading dose, leaving 59 participants in the primary analyses (40 treatment, 19 placebo). Thirty-one/38 (81.6%) participants in the treatment arm achieved a plasma 25(OH)D concentration > 75 nmol/L versus 1/18 (5.6%) the placebo arm. The mean 25(OH)D concentration in the treatment arm was 125.9 nmol/L (SD 63.4). There was no evidence of vitamin D toxicity and no major drug or safety protocol violations. The accrual rate was 3.4 patients/month, supporting feasibility of a larger trial. A day 7 blood sample was collected for 84% of patients. A survey administered to 40 participating families showed that health-related quality of life (HRQL) was the most important outcome for families for the main trial (30, 75%). CONCLUSIONS: A single 10,000 IU/kg dose can rapidly and safely normalize plasma 25(OH)D concentrations in critically ill children with VDD, but with significant variability in 25(OH)D concentrations. We established that a phase III multicentre trial is feasible. Using an outcome collected after hospital discharge (HRQL) will require strategies to minimize loss-to-follow-up. CLINICALTRIALS: gov NCT02452762 Registered 25/05/2015.
Subject(s)
Cholecalciferol , Vitamin D Deficiency , Adult , Humans , Child , Cholecalciferol/therapeutic use , Critical Illness/therapy , Quality of Life , Feasibility Studies , Double-Blind Method , Vitamin D , Vitamins/therapeutic use , Vitamin D Deficiency/drug therapy , Vitamin D Deficiency/complications , Intensive Care Units, Pediatric , Dietary SupplementsABSTRACT
Este trabajo presenta la elaboración del Test de Alfabetización Económica para Adultos, versión 25 Items (TAE-A-25), derivado de un instrumento homónimo de mayor longitud construido previamente por los autores. El TAE-A-25 es una prueba compuesta por items de elección múltiple, de 4 alternativas, y está inspirado en el Test of Economic Literacy (TEL) para adolescentes (Soper & Walstad, 1987). Sus items abarcan cuatro áreas de conocimientos básicos sobre economía y evalúan conceptos y habililidades procedimentales. Se presentan análisis realizados a partir de la Teoría Clásica de los Tests sobre las respuestas dadas al instrumento por una muestra de 840 adultos chilenos de ambos géneros, entre 18 y 50 años. Los análisis permitieron obtener un instrumento de 25 items, con adecuados niveles de dificultad (.24 < p < .76), discriminación (.27 < p < .54), y confiabilidad (GLB=.87), además de óptimo comportamiento de los distractores. Se discuten los resultados y se comentan las limitaciones del instrumento.(AU)
This paper presents the development of the Test of Economic Literacy for Adults, version of 25 items (TAE-A-25), derived from a test previously constructed by the authors. The TAE-A-25 is composed for multiple-choice items, with 4 options, and it's inspired in the Test of Economic Literacy (TEL) for adolescents (Soper & Walstad, 1987). Their items include four areas of basic knowledge on economy and evaluate conceptual understanding and procedural skills. The analyses where realized in the Classical Test Theory framework, based on a sample of 840 male and female Chileans, aged between 18 and 50 years. The analyses allowed to obtain a test of 25 items, with appropriate levels of difficulty (24 < p < 76), discrimination (27 < p < 54), and reliability (GLB=.87), in addition to optimal performance of the item options. The results are discussed and the limitations of the test commented.(AU)
ABSTRACT
Este trabajo presenta la elaboración del Test de Alfabetización Económica para Adultos, versión 25 Items (TAE-A-25), derivado de un instrumento homónimo de mayor longitud construido previamente por los autores. El TAE-A-25 es una prueba compuesta por items de elección múltiple, de 4 alternativas, y está inspirado en el Test of Economic Literacy (TEL) para adolescentes (Soper & Walstad, 1987). Sus items abarcan cuatro áreas de conocimientos básicos sobre economía y evalúan conceptos y habililidades procedimentales. Se presentan análisis realizados a partir de la Teoría Clásica de los Tests sobre las respuestas dadas al instrumento por una muestra de 840 adultos chilenos de ambos géneros, entre 18 y 50 años. Los análisis permitieron obtener un instrumento de 25 items, con adecuados niveles de dificultad (.24 < p < .76), discriminación (.27 < p < .54), y confiabilidad (GLB=.87), además de óptimo comportamiento de los distractores. Se discuten los resultados y se comentan las limitaciones del instrumento.
This paper presents the development of the Test of Economic Literacy for Adults, version of 25 items (TAE-A-25), derived from a test previously constructed by the authors. The TAE-A-25 is composed for multiple-choice items, with 4 options, and it's inspired in the Test of Economic Literacy (TEL) for adolescents (Soper & Walstad, 1987). Their items include four areas of basic knowledge on economy and evaluate conceptual understanding and procedural skills. The analyses where realized in the Classical Test Theory framework, based on a sample of 840 male and female Chileans, aged between 18 and 50 years. The analyses allowed to obtain a test of 25 items, with appropriate levels of difficulty (24 < p < 76), discrimination (27 < p < 54), and reliability (GLB=.87), in addition to optimal performance of the item options. The results are discussed and the limitations of the test commented.
