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IRCT20160120026115N8 IRCT 2022-02-26 Iran University of Medical Sciences Comparison of Intramuscular and Oral Vitamin D Treatment in Preterm Infants Comparison of vitamin D levels after oral and intramascular vitamin D treatment in premature infants with vitamin D deficiency 2020-11-21 anticipated 90 Complete https://irct.ir/trial/37097 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In Simple Random Sampling, each element of the target community has an equal chance of being selected. In this study, we used the sampling method using Excel software. In this way, the numbers 1 to 91 using the command: = Randbetween (1.91) That Randbetween is a variable function. This command was given to the software and the software randomly places these numbers in a column as a table of random and random numbers. Then the first 45 are assigned to the first treatment and the second 45 to the second treatment. Random numbers are the same as the number of people entering the study, which are as follows: Random samples extracted in the first group: (15, 61,68,6,37,41,76,23,81,43,56,13,35,10,60,12,51,28,4,17,71,26,65,38,20 , 33,72,87,82,11, 53,1,91,58,44,85,2,75,67,50,70,45,64,79,46) (48,55,62,36,84,39,49,77,69,47,8,34,22,59,5,83,30,66,52,27,19,73,42,18,9 , 24,80,78,88,40,3,7,32,25,57,31,54,21,74,14,29,63,86,16,90) These numbers are such that the people who enter in numbers 15, 61, 68, etc .; To the first treatment and those who enter 48, 55, 62, etc .; Are assigned to the second treatment. Follow-up of patients on the 16th day after administration of the drug by measurement of vitamin D, calcium, phosphorus and serum alkaline phosphatase. Took. 3 Vitamin D deficiency. Intervention 1: Intervention group: Intramuscular injection of vitamin D( injection 15000 units per day single dose). Intervention 2: Control group: Prescribing oral vitamin D (oral drops of 1000 units, 1ml daily up to 15 Days ). Yes - There is a plan to make this available What will be shared: All data is potentially shareable after making individuals unidentifiable When: The access period starts one year after the results are published. To whom: Researchers working in academic institutions Conditions: The data are allowed for further studies on this research topic. Where to obtain: Leila Irani/ Iran University of Medical Sciences/ Iran University of Medical Sciences, Hemmat highway/ or Email address: kashakimd@gmail.com How to obtain: Written request or email Comments:
public Mandana Kashaki
Molavi
Tehran Iran (Islamic Republic of) 1168743514 +98 21 5560 6034 kashakimd@gmail.com Iran University of Medical Sciences scientific Mandana Kashaki
Molavi
Tehran Iran (Islamic Republic of) 1168743514 +98 21 5560 6034 kashakimd@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) All premature infants in the NICU ward Vitamin D level within the range of deficiency. 14 days 28 days Both Premature infants who received oral or intravenous administration of vitamin D before the start of the study neonates have a malabsorption disease based on clinical presentation neonates with GFR less than 50 neonates with thyroid disorders E55.9 Vitamin D deficiency, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Intramuscular injection of vitamin D( injection 15000 units per day single dose) Control group: Prescribing oral vitamin D (oral drops of 1000 units, 1ml daily up to 15 Days ) Serum level in terms of vitamin D. Timepoint: At the beginning of the study and 14 days after treatment. Method of measurement: Lab tests. Iran University of Medical Sciences Approved 2018-10-28 Ethics Committee of Iran University of Medical Sciences Shaheed Akbarabadi Hospital, Molavi Street Tehran Tehran Iran (Islamic Republic of)