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 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- Government
- Canadian Institutes of Health Research
- University or hospital
- Institute of Human Development, Child and Youth Health
- University or hospital
- AHSC AFP Innovation Fund
- Authors
- At least one author declares a financial tie to industry
Based on 3 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2017-12-01 · Pilot Feasibility Stud · vol. 3 · issue 1 · p. 70
- Publisher
- BioMed Central
- Cited
- 33 citations · more than 76% of similar papers · 1.0× the field average
- References
- 52 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Vitamin D Research Studies · Vitamin K Research Studies · Adrenal Hormones and Disorders
- Keywords
- Cholecalciferol, Critically ill, Medicine, Randomized controlled trial, Vitamin, Protocol (science), vitamin D deficiency, Vitamin D and neurology, Pediatrics, Internal medicine, Alternative medicine, Pathology
13 authors
From CA, AT
- on behalf of the Canadian Critical Care Trials GroupUniversity of Ottawa; Children's Hospital of Eastern Ontario
- Dayre McNally · correspondingUniversity of Ottawa; Medical University of Graz; Children's Hospital of Eastern Ontario
- Karin AmreinMedical University of Graz; Children's Hospital of Eastern Ontario
- Katharine O’HearnUniversity of Ottawa; Children's Hospital of Eastern Ontario; Ottawa Hospital; Ottawa Hospital Research Institute
- Dean A. FergussonUniversity of Ottawa; Children's Hospital of Eastern Ontario; Ottawa Hospital; Ottawa Hospital Research Institute
- Pavel A. GeierUniversity of Ottawa; Children's Hospital of Eastern Ontario; Newborn Screening Ontario
Abstract
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.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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