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IRCT20221129056657N1 IRCT 2023-01-17 Mashhad University of Medical Sciences The effect of ultra-dose of vitamin D₃ on critical children Evaluation of the effect of ultra-dose of vitamin D₃ as 10000 IU/Kg on clinical and laboratory results of critical children admitted to PICU 2019-04-21 anticipated 138 Complete https://irct.ir/trial/67131 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual simple randomization Random number table randomization tool using www.randomization.com Allocation Concealment method: envelopes closed In this method, first, a random sequence is created, then based on the size of the research sample, a number of envelopes with aluminum wrappers (in order to avoid the clarity of the contents of the envelopes), are prepared and each of the generated random sequences is recorded on a card, and the cards are inside The letter envelopes are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: In order to perform blinding, ICU nurses, ICU doctors, the patient's treating physician, laboratory experts, statistical consultant,s and data analysts remained unaware of the method of randomization and placement of the patient in the assigned treatment group. N/A Vitamin D deficiency in critically ill children. Intervention 1: The usual dose of vitamin D₃ is 2000 IU orally (gavage), once a day, for 7 days - manufactured by Zahrawi Pharmaceutical Company, Tabriz. Intervention 2: Ultra dose of vitamin D₃ in the amount of 10000 IU/Kg orally (gavage) (maximum IU 400000), once a day, for 7 days, manufactured by Zahrawi Pharmaceutical Company, Tabriz. Yes - There is a plan to make this available What will be shared: Part of the data related to the main outcomes When: Six months after the results are published To whom: Academic institutions Conditions: For the purpose of research for the academic community Where to obtain: With Dr. Gholamreza Khademi, co-response author khademigh@mums.ac.ir How to obtain: Request via email to Dr. Gholamreza Khademi After the correspondence, the data will be sent about two weeks after the registration of the request. Comments:
public Gholamreza Khademi
Akbar Hospital, Shahid Kaveh Boulevard, Mashhad
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3871 3801 khademigh@mums.ac.ir Mashhad University of Medical Sciences scientific Gholamreza Khademi
Akbar Children's Hospital-Shahid Kaveh Boulevard - Mashhad
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3189 1780 khademigh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age of one month to 18 years Healthy children Critically ill children admitted to the PICU Healthy children 1 month 18 years Both Chronic kidney disease and nephritic syndrome Severe parenchymal or obstructive liver disease Vitamin D-dependent rickets type B1 (VDDR-1B) and type A1 (VDDR-1A) Hereditary vitamin D resistant rickets (HVDRR) High-dose glucocorticoid treatment AIDS treated with antiretroviral drugs Patients treated with phenytoin, phenobarbital, carbamazepine, isoniazid, theophylline and high doses of glucocorticoid Lack of oral or enteral nutrition Patients with hypercalcemia, intestinal malabsorption such as celiac disease and IBD, exocrine pancreatic disorder such as cystic fibrosis History of bowel resection or bariatric surgery Suffering from a chronic disease or current severe disease (in outpatients) Treatment - Drugs Treatment - Drugs The usual dose of vitamin D₃ is 2000 IU orally (gavage), once a day, for 7 days - manufactured by Zahrawi Pharmaceutical Company, Tabriz Ultra dose of vitamin D₃ in the amount of 10000 IU/Kg orally (gavage) (maximum IU 400000), once a day, for 7 days, manufactured by Zahrawi Pharmaceutical Company, Tabriz C-reactive protein factor. Timepoint: on the first day of the study and the seventh day after the intervention. Method of measurement: Taking blood samples and laboratory kits. Length of hospitalization in the intensive care unit. Timepoint: On the seventh day after the intervention. Method of measurement: Refer to the patient file. Percentage of possible mortality. Timepoint: First day of study. Method of measurement: Completing the Prism form. Duration of hospitalization. Timepoint: The seventh day after the start of the intervention. Method of measurement: Complete the checklist. Duration of intubation. Timepoint: The seventh day after the start of the intervention. Method of measurement: Complete the checklist. Vitamin D levels. Timepoint: The first day of the study and the seventh day after the start of the intervention. Method of measurement: Using the ELISA laboratory kit (Enzyme-linked immuno_sorbent assay). Mashhad University of Medical Sciences Approved 2019-04-17 Ethics Committee of Mashhad University of Medical Sciences Akbar hospital, Kaveh Blvd., Mashhad Town Mashhad Razavi Khorasan Iran (Islamic Republic of)