Give ICU children a bolus dose of 10,000 IU of vitamin D per kg – RCT underway
Rapid normalization of vitamin D deficiency in PICU (VITdALIZE-KIDS): study protocol for a phase III, multicenter randomized controlled trial
Trials. 2024 Sep 19;25(1):619. doi: 10.1186/s13063-024-08461-7.
Katie O'Hearn 1, Kusum Menon 1 2, Lisa Albrecht 1, Karin Amrein 3, Philip Britz-McKibbin 4, Florence Cayouette 5, Karen Choong 6, Jennifer Ruth Foster 7 8, Dean A Fergusson 9 10 11, Alejandro Floh 12 13, Patricia Fontela 14 15, Pavel Geier 1 2, Elaine Gilfoyle 12 16, Gonzalo Garcia Guerra 17 18 19, Anna Gunz 20, Erick Helmeczi 4, Ali Khamessan 21, Ari R Joffe 19 22, Laurie Lee 23 24, Lauralyn McIntyre 10 25, Srinivas Murthy 26, Simon J Parsons 17, Tim Ramsay 9 10, Lindsay Ryerson 19 22, Marisa Tucci 27, Dayre McNally 28 29; Canadian Critical Care Trials Group
Background: The 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.
Methods: Our 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 registration: Clinicaltrials.gov, NCT03742505. Study first submitted on November 12, 2018 https://clinicaltrials.gov/study/NCT03742505.
📄 Download the PDF from Vitamin D Life
Note: The RCT is giving Vitamin D as 50,000 IU per ml of fluid (does not indicate if it is water soluble or fat-soluble)
Note: Predict that the 90 day measurements will show little benefit. The bolus vitamin D will have dissipated by then
Large dose of vitamin D (200,000 IU) lasts for less than 90 days – Feb 2015 - chart
Note: RCT is not giving a gut-friendly form of the vitamin D
Gut-friendly forms include
Swallowed (emulsion or water soluble),
Swished in mouth and absorbed by mouth tissues
Applied topically to skin
It appears that the RCT will be giving an oil-based liquid form of vitamin D, which has the least bio-availability in ill people of any age
Note: Their form takes about 5 days to peak, some other forms peak 2X or 3X faster
Especially topical form
Topical Vitamin D category contains:
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Note: Many other RCTs has found great benefit when bolus vitamin D is given a week before BEFORE entering the ICU
__Vitamin D is needed before many surgeries – many studies and RCTs
Vitamin D Life - studies in both categories Infant-Child and Trauma Surgery
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Vitamin D Life - studies in both categories Infant-Child and Loading Dose
This list is automatically updated
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