Study protocol for supplementation of single high dose Vitamin D in deficient critically ill children and assessment of their short-term outcome: An open label randomized control trial

Abstract

Vitamin D, traditionally linked to bone metabolism, plays pleotropic roles in cellular regulation. In critically ill children, Vitamin D deficiency is associated with adverse outcomes, motivating our open-label Randomized Control Trial. Our aim is to assess short-term outcomes in Vitamin D-deficient critically ill children following a single high oral dose. Conducted at a central Indian tertiary care hospital with a sample size of 100, participants aged 1 month to 18 years will be randomized. Group A receives standard treatment with customary cholecalciferol dosing, while Group B receives standard treatment with a single high oral/nasogastric tube dose (10,000 IU/kg to 400,000 IU) of Vitamin D. Outcomes include PICU stay duration, mechanical ventilation period, occurrences of Ventilator-Associated Pneumonia and Central Line-Associated Blood Stream Infection, instances of Acute Kidney Injury, presence of Multiorgan dysfunction, maximum Vasoactive-Inotrope Score, and mortality rates. Results and interpretation will be guided by study observations. Trial registration: CTRI/2022/10/046556.