Evidence map›Paper›PMID 37580663›Full record

Trial reportBMC pediatrics2023

A phase II dose evaluation pilot feasibility randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study).

Katie O'Hearn, Kusum Menon, Hope A Weiler, Karin Amrein, Dean Fergusson, Anna Gunz, Raul Bustos, Roberto Campos, Valentina Catalan, Siegfried Roedl and 12 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pediatrics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02452762 (Rapid Normalization of Vitamin D in Critically Ill Children), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 20% of its field
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.

NCT02452762 phase2completednot on this map

Rapid Normalization of Vitamin D in Critically Ill Children: A Phase II Dose Evaluation Randomized Controlled Trial

TypeinterventionalSponsorChildren's Hospital of Eastern OntarioRan2016 to 2018Enrolled67ConditionsHypovitaminosis DArmsVitamin D3, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Effect of Single High Dose Vitamin D Administration in Critically Ill Vitamin D-deficient Pediatric Patients: A Randomized Trial.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2025
    Article
  3. Article
  4. Review
  5. Vitamin D may influence disease course in PIMS-TS/MIS-C: An observational cohort study.Pediatrics international : official journal of the Japan Pediatric Society
    Observational
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

22 authors at 8 institutions in 3 countries.

Katie O'HearnResearch Institute, Children's Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada.
Kusum MenonResearch Institute, Children's Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada.
Hope A WeilerSchool of Human Nutrition, Faculty of Agricultural and Environmental Sciences, McGill University, Montreal, Canada.
Karin AmreinDivision of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
Dean FergussonFaculty of Medicine, University of Ottawa, Ottawa, Canada.
Anna GunzDepartment of Paediatrics, Schulich School of Medicine & Dentistry, Western University, London, ON, N6A 5W9, Canada.
Raul BustosClínica Sanatorio Alemán, Unidad de Cuidados Intensivos Pediátricos, Concepción, Chile.
Roberto CamposClínica Sanatorio Alemán, Unidad de Cuidados Intensivos Pediátricos, Concepción, Chile.
Valentina CatalanClínica Sanatorio Alemán, Unidad de Cuidados Intensivos Pediátricos, Concepción, Chile.
Siegfried RoedlDepartment of Paediatrics and Adolescent Medicine, Joint Facilities, Medical University of Graz, Graz, Austria.
Anne TsampalierosClinical Research Unit, Children's Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada.
Nick BarrowmanClinical Research Unit, Children's Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada.
Pavel GeierDepartment of Pediatrics, Faculty of Medicine, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Canada.
Matthew HendersonResearch Institute, Children's Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada.
Ali KhamessanEuro-Pharm International Canada Inc, Montreal, Canada.
Margaret L LawsonResearch Institute, Children's Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada.
Lauralyn McIntyreDepartment of Medicine (Division of Critical Care), Ottawa Hospital Research Institute (OHRI), University of Ottawa, Ottawa, Canada.
Stephanie RedpathDepartment of Pediatrics, Faculty of Medicine, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Canada.
Glenville JonesDepartment of Biomedical and Molecular Sciences, Queen's University, Kingston, Canada.
Martin KaufmannDepartment of Biomedical and Molecular Sciences, Queen's University, Kingston, Canada.
Dayre McNallyResearch Institute, Children's Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada. dmcnally@cheo.on.ca.
Canadian Critical Care Trials Group
Children's Hospital of Eastern Ontario · CAClínica Alemana · CLUniversity of Ottawa · CAMedical University of Graz · ATQueen's University · CAMcGill University · CAOttawa Hospital · CAWestern University · CA

Funding

CIHR
6 · The paper itself

Abstract

backgroundVitamin 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.

methodsWe 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.

resultsOf 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%).

conclusionsA 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.

trial registrationCLINICALTRIALS: gov NCT02452762 Registered 25/05/2015.

Indexed as

CholecalciferolVitamin D DeficiencyAdultChildCritical IllnessDietary SupplementsDouble-Blind MethodFeasibility StudiesHumansIntensive Care Units, PediatricQuality of LifeVitamin DVitaminsCholecalciferolVitamin DVitaminsCritical careFeasibilityPediatricsRandomized controlled trialVitamin DVitamin D deficiency

Identifiers

PMID37580663
PMCPMC10424361
OpenAlexW4385808968

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.