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IRCT20130424013110N10 IRCT 2020-07-06 Arak University of Medical Sciences Effect of co_administration of vitamins A and D in patients with pneumosepsis Effect of co_administration of vitamins A and D compared to placebo on the level of regulatory T cells in pneumosepsis patients: a randomized clinical trial 2020-07-05 anticipated 44 Complete https://irct.ir/trial/41150 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study the randomization will be done using block randomization method. In order to allocate the patients randomly into two groups of treatment and control, at first 11 blocks of size 4 with C and T letters (The letters indicate the intervention and control groups) are created in each 2 patients are belonged to the intervention group and 2 patients are belonged to the control group). Then the blocks are randomly selected and arranged to obtain a sequential combination of 44 letters. Each letter will be placed in a sealed packet according to the obtained sequence, Blinding description: First (intervention) group receive 300000 unit vitamin D (1 milliliter), Intramuscular (IM) with 50000 unit vitamin A (1 milliliter), Intramuscular (IM) as a single dose. Second (control) group receive, 2 milliliter normal saline as placebo, single dose, intramuscularly. Therefore, patients will be unaware of the type of intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as double blind. 2-3 Pneumosepsis. Intervention 1: Intervention group: First (intervention) group receive, 300000 unit vitamin D (1 milliliter), Intramuscular (IM) with 50000 unit vitamin A (1 milliliter), Intramuscular (IM) as a single dose. Intervention 2: Control group: Second (control) group receive, 2 milliliter normal saline as placebo, single dose, intramuscularly. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Dr Atefeh Pooyandeh
Valiasr Hospital, Valiasr square, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 dr.a.jokar@gmail.com Arak University of Medical Sciences scientific Dr Abolfazl Jokar
Valiasr Hospital, Valiasr Square, Arak
Arak Iran (Islamic Republic of) 3848176341 +98 86 3222 2003 dr.a.jokar@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Age 18 to 80 years old Patients satisfaction Hospitalized for at least 3 days Confirmed pneumosepsis disease 18 years 80 years Both Unwillingness to cooperate Using Vitamin D supplements before intervention in the last three months Pregnancy A41 Other sepsis Treatment - Drugs Placebo Intervention group: First (intervention) group receive, 300000 unit vitamin D (1 milliliter), Intramuscular (IM) with 50000 unit vitamin A (1 milliliter), Intramuscular (IM) as a single dose. Control group: Second (control) group receive, 2 milliliter normal saline as placebo, single dose, intramuscularly Regulatory T Cells frequency. Timepoint: Before and 72 hours after the intervention. Method of measurement: Frequency of desired cells using Flow Cytometry Technique. Arak University of Medical Sciences Approved 2020-06-10 Ethics committee of Arak University of Medical Sciences Vice Chancellery For Research And Technology; University campus; Basij square; Arak Arak Markazi Iran (Islamic Republic of)