Study protocol for a phase II dose evaluation randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study)
McNally D, Amrein K, O'Hearn K, Fergusson D, Geier P, Henderson M, Khamessan A, Lawson ML, McIntyre L, Redpath S, Weiler HA, Menon K, Canadian Critical Care Trials Group
Pilot and feasibility studies · 14 citas
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- Ensayo controlado aleatorizado (clasificado por nuestro filtro de IA)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Canadian Institutes of Health Research
- Universidad u hospital
- Institute of Human Development, Child and Youth Health
- Universidad u hospital
- AHSC AFP Innovation Fund
- Autores
- Al menos un autor declara un vínculo económico con la industria
Según 3 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2017-12-01 · Pilot Feasibility Stud · vol. 3 · número 1 · pág. 70
- Editorial
- BioMed Central
- Citado
- 33 citas · más que el 76% de estudios similares · 1.0× el promedio de su campo
- Referencias
- 52 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Vitamin D Research Studies · Vitamin K Research Studies · Adrenal Hormones and Disorders
- Palabras clave
- Cholecalciferol, Critically ill, Medicine, Randomized controlled trial, Vitamin, Protocol (science), vitamin D deficiency, Vitamin D and neurology, Pediatrics, Internal medicine, Alternative medicine, Pathology
13 autores
- on behalf of the Canadian Critical Care Trials Group🇨🇦University of Ottawa; Children's Hospital of Eastern Ontario
- Dayre McNally🇨🇦🇦🇹 · autor de correspondenciaUniversity of Ottawa; Medical University of Graz; Children's Hospital of Eastern Ontario
- Karin Amrein🇦🇹🇨🇦Medical University of Graz; Children's Hospital of Eastern Ontario
- Katharine O’Hearn🇨🇦University of Ottawa; Children's Hospital of Eastern Ontario; Ottawa Hospital; Ottawa Hospital Research Institute
- Dean A. Fergusson🇨🇦University of Ottawa; Children's Hospital of Eastern Ontario; Ottawa Hospital; Ottawa Hospital Research Institute
- Pavel A. Geier🇨🇦University of Ottawa; Children's Hospital of Eastern Ontario; Newborn Screening Ontario
- M. David Henderson🇨🇦Newborn Screening Ontario
- Ali Khamessan🇨🇦University of Ottawa; Children's Hospital of Eastern Ontario
- Margaret L. Lawson🇨🇦University of Ottawa; Children's Hospital of Eastern Ontario; Ottawa Hospital
- Lauralyn McIntyre🇨🇦University of Ottawa; Children's Hospital of Eastern Ontario; Ottawa Hospital
- Stephanie Redpath🇨🇦University of Ottawa; Children's Hospital of Eastern Ontario; McGill University
- Hope Alberta Weiler🇨🇦University of Ottawa; Children's Hospital of Eastern Ontario; McGill University
- Kusum Menon🇨🇦University of Ottawa; Children's Hospital of Eastern Ontario
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Clinical research has recently demonstrated that vitamin D deficiency (VDD) is highly prevalent in the pediatric intensive care unit (PICU) and associated with worse clinical course. Multiple adult ICU trials have suggested that optimization of vitamin D status through high-dose supplementation may reduce mortality and improve other clinically relevant outcomes; however, there have been no trials of rapid normalization in the PICU setting. The objective of this study is to evaluate the safety and efficacy of an enteral weight-based cholecalciferol loading dose regimen in critically ill children with VDD.
Methods/design
The VITdAL-PICU pilot study is designed as a multicenter placebo-controlled phase II dose evaluation pilot randomized controlled trial. We aim to randomize 67 VDD critically ill children using a 2:1 randomization schema to receive loading dose enteral cholecalciferol (10,000 IU/kg, maximum of 400,000 IU) or a placebo solution. Participants, caregivers and outcome assessors will be blinded to allocation. Eligibility criteria include ICU patient, aged 37 weeks to 18 years, expected ICU length of stay more than 48 h, anticipated access to bloodwork at 7 days, and VDD (blood total 25 hydroxyvitamin D < 50 nmol/L). The primary objective is to determine whether the dosing protocol normalizes vitamin D status, defined as a blood total 25(OH)D concentration above 75 nmol/L. Secondary objectives include an examination of the safety of the dosing regimen (e.g. hypercalcemia, hypercalciuria, nephrocalcinosis), measures of vitamin D axis function (e.g. calcitriol levels, immune function), and protocol feasibility (eligibility criteria, protocol deviations, blinding).
Discussion
Despite significant observational literature suggesting VDD to be a modifiable risk factor in the PICU setting, there is no robust clinical trial evidence evaluating the benefits of rapid normalization. This phase II clinical trial will evaluate an innovative weight-based dosing regimen intended to rapidly and safely normalize vitamin D levels in critically ill children. Study findings will be used to inform the design of a multicenter phase III trial evaluating the clinical and economic benefits to rapid normalization. Recruitment for this trial was initiated in January 2016 and is expected to continue until November 30, 2017.
Trial registration
Clinicaltrials.gov NCT02452762.
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