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IRCT20230224057514N1 IRCT 2023-03-15 Karaj University of Medical Sciences Vitamin D in knee osteoarthritis Comparing the effectiveness of platelet-enriched plasma along with vitamin D and platelet-enriched plasma without vitamin D in improving function and reducing pain in knee osteoarthritis patients 2023-04-21 anticipated 100 Complete https://irct.ir/trial/69051 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method will be used for randomization. The length of the block is considered to be 4 for each of the treatment groups, that is, each block will include two people from the intervention group and two people from the comparison group. We denote the intervention group with the letter A and the people of the comparison group with the letter B. In this case, we will have 6 combinations of four in the form of (AA,BB), (AB,BA), (BA,BA), (BA,BA), (BB,AA), and (AB,BA). In the Excel software, these blocks are sorted from 1 to 6, and then with the help of this software, one of these blocks is randomly selected, and based on the sequence of letters A and B in the selected block, the eligible people refer to and Admissions will be assigned to treatment or comparison groups. This random process of selecting blocks and assigning people to intervention and comparison groups will continue until the desired sample size is reached, Blinding description: This study is designed in a triple-blind manner, so that the injector, the outcome assessor and the patient are not aware of the status of assigning people to the study groups. For the study subjects, before the random allocation, it is explained how the work process is and they may receive one of the two treatments randomly, and the drug used for the subjects is not known in advance. On the other hand, the injection of vitamin D and PRP in the intervention group is done in the same syringe as in the PRP only (comparison) group, so the patient will be unaware of which group he is in. The injecting person will also be unaware of the patients' belonging to the treatment groups, because the sampling and preparation of the injectable substance is done by another person, and after entering the study, people will be anonymously and with a code to the injecting agent. they are introduced. Also, the outcome evaluator will not know about the status of assigning people to the study groups. N/A Osteoarthritis of the knee joint. Intervention 1: Intervention group: In the intervention group, first, 20 ml of blood is taken from the patient and centrifuged for 15 minutes at 1600 rpm to separate the erythrocytes and then 7 minutes at 2800 rpm to concentrate the platelets, then 300,000 IU of vitamin D solution is added to it. 8 minutes before the injection, the skin of the injection site is anesthetized by injecting 2 ml of 1% lidocaine. 3 ml of the prepared solution is drawn into a syringe and injected into the knee joint. Intervention 2: Control group: All the above cases are also done for the comparison group, with the difference that in this group, the injected solution does not contain vitamin D. Yes - There is a plan to make this available What will be shared: Participants Data File, Study Protocol, Statistical Analysis Map, Consent Form and Clinical Study Report will be shared after completion of the study.Participants' data file is not identifiable by others When: The data of this study will be shared one month after printing the results and will be available for one year To whom: All researchers interested in research in this study can access data Conditions: 1.People who request access to data must be committed to the intellectual rights of researchers. 2.Avoid data manipulation and consequently unrealistic analysis. Where to obtain: Researchers interested in access to data in this study can refer to the clinical research unit of Shahid Madani Hospital How to obtain: Researchers interested in access to data in this study can refer to the Shahid Madani Hospital Clinical Research Development Unit and submit their official request to access data. After making the necessary reviews and obligations, the data will be made available to them. Comments:
public Amirhossein Haghshenas
Shahid Madani hospital, Mahan blvd, Jahanshahr, Karaj
Karaj Iran (Islamic Republic of) 3143746693 +98 26 3442 7001 face.off1990amir@gmail.com Karaj University of Medical Sciences scientific Amirhossein Haghshenas
Shahid Madani hospital, Mahan blvd, Jahahnshahr, Karaj
Karaj Iran (Islamic Republic of) 3143746693 +98 26 3442 7001 face.off1990amir@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Having informed consent Suffering from osteoarthritis based on the criteria of the American Rheumatology Association Receiving non-invasive treatments for at least 6 months Having a body mass index below 30 50 years 60 years Both History of fracture or previous surgery on the studied joint Diagnosis of secondary osteoarthritis History of drug sensitivity M17 Osteoarthritis of knee Treatment - Drugs Treatment - Other Intervention group: In the intervention group, first, 20 ml of blood is taken from the patient and centrifuged for 15 minutes at 1600 rpm to separate the erythrocytes and then 7 minutes at 2800 rpm to concentrate the platelets, then 300,000 IU of vitamin D solution is added to it. 8 minutes before the injection, the skin of the injection site is anesthetized by injecting 2 ml of 1% lidocaine. 3 ml of the prepared solution is drawn into a syringe and injected into the knee joint. Control group: All the above cases are also done for the comparison group, with the difference that in this group, the injected solution does not contain vitamin D Knee joint pain. Timepoint: Pain measurement will be done at the beginning of the study, the first week, the first month, the second month and the sixth month after the treatment. Method of measurement: Vas score index. Functional status of the knee joint. Timepoint: The functional condition of the knee joint will be examined at the beginning of the study, the first week, the first month, the second month and the sixth month after the treatment. Method of measurement: WOMAC score index. Karaj University of Medical Sciences Approved 2023-02-19 Ethics committee of Alborz University of Medical Sciences Vice President of Research and Technology of Alborz University of Medical Sciences, Safarian St, Golshahr, Karaj Karaj Alborz Iran (Islamic Republic of)