Evidence map›Paper›PMID 39300483›Full record

ArticleTrials2024

Rapid normalization of vitamin D deficiency in PICU (VITdALIZE-KIDS): study protocol for a phase III, multicenter randomized controlled trial.

Katie O'Hearn, Kusum Menon, Lisa Albrecht, Karin Amrein, Philip Britz-McKibbin, Florence Cayouette, Karen Choong, Jennifer Ruth Foster, Dean A Fergusson, Alejandro Floh and 17 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03742505 (Rapid Normalization of Vitamin D Deficiency in PICU), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03742505 phase3completednot on this map

Rapid Normalization of Vitamin D Deficiency in PICU: A Multi-Centre Phase III Double-Blind Randomized Controlled Trial

TypeinterventionalSponsorChildren's Hospital of Eastern OntarioRan2019 to 2024Enrolled424ConditionsVitamin D DeficiencyArmsCholecalciferol, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. The Role of Vitamin D and Vitamin D Receptor in Sepsis.Current issues in molecular biology · 2025
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Katie O'HearnCHEO Research Institute, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.
Kusum MenonCHEO Research Institute, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.
Lisa AlbrechtCHEO Research Institute, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.
Karin AmreinDivision of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
Philip Britz-McKibbinDepartment of Chemistry and Chemical Biology, McMaster University, Hamilton, ON, Canada.
Florence CayouetteDepartment of Pediatrics, Critical Care Division, Centre Mère-Enfant Soleil du CHU de Québec, Université Laval, Quebec City, QC, Canada.
Karen ChoongDepartments of Pediatrics and Critical Care, McMaster Children's Hospital, McMaster University, Hamilton, ON, Canada.
Jennifer Ruth FosterDepartment of Pediatric Critical Care, IWK Health, Halifax, NS, Canada.
Dean A FergussonSchool of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
Alejandro FlohDepartment of Critical Care Medicine, The Hospital for Sick Children, Toronto, ON, Canada.
Patricia FontelaDivision of Pediatric Critical Care, Department of Pediatrics, McGill University, Montreal, QC, Canada.
Pavel GeierCHEO Research Institute, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.
Elaine GilfoyleDepartment of Critical Care Medicine, The Hospital for Sick Children, Toronto, ON, Canada.
Gonzalo Garcia GuerraPediatric Critical Care, Department of Pediatrics, University of Calgary, Alberta Children's Hospital, Calgary, Canada.
Anna GunzDepartment of Paediatrics, Schulich School of Medicine & Dentistry, Western University, Children's Health Research Institute, LondonLondon, ONON, Canada.
Erick HelmecziDepartment of Chemistry and Chemical Biology, McMaster University, Hamilton, ON, Canada.
Ali KhamessanEuro-Pharm International Canada Inc, Montreal, Canada.
Ari R JoffeStollery Children's Hospital, Edmonton, AB, Canada.
Laurie LeeDepartment of Pediatrics, Cummings School of Medicine, University of Calgary, Calgary, AB, Canada.
Lauralyn McIntyreOttawa Hospital Research Institute, Ottawa, ON, Canada.
Srinivas MurthyDivision of Critical Care, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.
Simon J ParsonsPediatric Critical Care, Department of Pediatrics, University of Calgary, Alberta Children's Hospital, Calgary, Canada.
Tim RamsaySchool of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
Lindsay RyersonStollery Children's Hospital, Edmonton, AB, Canada.
Marisa TucciDivision of Pediatric Critical Care Medicine, Department of Pediatrics, Sainte Justine and Montreal Heart Institute, University of Montreal, Montreal, QC, Canada.
Dayre McNallyCHEO Research Institute, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada. dmcnally@cheo.on.ca.
Canadian Critical Care Trials Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe rate of vitamin D deficiency (VDD) in critically ill children worldwide has been estimated at 50%. These children are at risk of multiple organ dysfunction, chronic morbidity, and decreased health related quality of life (HRQL). Pediatric and adult ICU clinical trials suggest that VDD is associated with worse clinical outcomes, although data from supplementation trials are limited and inconclusive. Our group's phase II multicenter dose evaluation pilot study established the efficacy and safety of an enteral weight-based cholecalciferol loading dose to rapidly restore vitamin D levels in critically ill children.

methodsOur aim is to evaluate the impact of this dosing regimen on clinical outcomes. VITdALIZE-KIDS is a pragmatic, phase III, multicenter, double-blind RCT aiming to randomize 766 critically ill children from Canadian PICUs. Participants are randomized using a 1:1 scheme to receive a single dose at enrollment of enteral cholecalciferol (10,000 IU/kg, max 400,000 IU) or placebo. Eligibility criteria include critically ill children aged newborn (> 37 weeks corrected gestational age) to < 18 years who have blood total 25-hydroxyvitamin D < 50 nmol/L. The primary objective is to determine if rapid normalization of vitamin D status improves HRQL at 28 days following enrollment. The secondary objective is to evaluate the impact of rapid normalization of vitamin D status on multiple organ dysfunction. The study includes additional tertiary outcomes including functional status, HRQL and mortality at hospital discharge and 90 days, PICU and hospital length of stay, and adverse events related to vitamin D toxicity. Additionally, we are performing comprehensive vitamin D speciation and non-targeted metabolite profiling as part of a sub-study for the first 100 participants from whom an enrollment and at least one post-intervention blood and urine sample were obtained. DISCUSSION: The VITdALIZE-KIDS trial is the first phase III, multicenter trial to evaluate whether rapid normalization of vitamin D status could represent a simple, inexpensive, and safe means of improving outcomes following pediatric critical illness. Recruitment was initiated in June 2019 and is expected to continue to March 2026.

trial registrationClinicaltrials.gov, NCT03742505. Study first submitted on November 12, 2018 https://clinicaltrials.gov/study/NCT03742505.

Indexed as

CholecalciferolClinical Trials, Phase III as TopicCritical IllnessIntensive Care Units, PediatricMulticenter Studies as TopicVitamin DVitamin D DeficiencyAdolescentBiomarkersCanadaChildChild, PreschoolDouble-Blind MethodFemaleHumansInfant25-hydroxyvitamin DBiomarkersCholecalciferolVitamin DCritical careHealth-related quality of lifePediatricsRandomized controlled trialVitamin DVitamin D deficiency

Identifiers

PMID39300483
PMCPMC11414195

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.