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 is a fat-soluble vitamin and is classically considered to play a major role in bone metabolism and maintaining Calcium and phosphorus equilibrium. With progressing research, other roles of Vitamin D are surfacing. The pleotropic functions of Vitamin D regulate cell proliferation, differentiation, apoptosis, and angiogenesis. In critically ill children, Vitamin D deficiency is associated with poor outcomes in the form of increased PICU stay, increased duration of mechanical ventilation, higher rate of Ventilator Associated Pneumonias, increased incidence of sepsis, higher intensive care scores and increased incidence of end organ dysfunction. With this background, we aim to conduct an open label Randomized Control Trial to study the short-term outcome of Vitamin D deficient critically ill children after supplementation of a single high dose oral Vitamin D. This will be an open label randomized control trial conducted at a tertiary care hospital in central India. Children aged 1 month to 18 years, admitted in the pediatric intensive care unit with Serum Vitamin D level less than 20 ng/dL will be the study group. These children will be randomized into two groups as per the computer-generated randomization. Group A will receive standard treatment protocol with 10,000 IU/Kg to 400,000 IU (maximum) Vitamin D via mouth or nasogastric tube, whereas Group B will receive standard treatment protocol. Urinary calcium-creatinine ratio will be done on day 3 in Group A to check for hypervitaminosis D. The outcome of both the groups will be assessed. All the data will be added to a Microsoft Excel sheet. Results and interpretation will be determined on the basis of the obtained observation. Trial registration: CTRI/2022/10/046556.