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IRCT20170104031773N2 IRCT 2019-03-08 Shahid Beheshti University of Medical Sciences Vitamin D in ischemic stroke Investigating of vitamin D administration on the level of inflammatory factors and functional and cognitive scores in patients with cerebral ischemic stroke 2018-09-23 anticipated 30 Complete https://irct.ir/trial/35291 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, Random numbers table, Blinding description: participants, Clinical care and the individual who evaluates the outcome. N/A Ischemic stroke. Intervention 1: First intervention group: Injection of two vitamins D 3 with a dose of 300,000 units. The first dose is taken after confirmation vitamin D deficiency at the beginning of the disease, and the second dose is one month after the first dose. It used Intramuscular and the drug belongs to the Osweh Pharmaceutical Company. Intervention 2: Second intervention group: The patient will receive 6 pearls of vitamin D3 orally at a dose of 50,000 units.The first dose is taken after confirmation of vitamin D deficiency in the patient and next doses are taken weekly after the first dose. The drug belongs to Dana Pharmaceutical Company. Intervention 3: Control group: In this group, the drug is not given to the patient and only the level of vitamin D is measured at the beginning and one month later. Yes - There is a plan to make this available What will be shared: Part of the data which is the main consequence of the study When: Start the access period 6 months after printing the results To whom: Researchers working in academia and industry Conditions: Therapeutic use Where to obtain: Leila Simani l.simani90@sbmu.ac.ir How to obtain: After submitting the request and checking the available items,The data is obtained Comments:
public Leila Simani
Loghman Hakim Hospital, Makhsoos St., Lashkar CUV.
Tehran Iran (Islamic Republic of) 1333631151 +98 21 5102 5182 l.simani90@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Leila Simani
Loghman Hakim Hospital, Makhsoos St., Lashkar CUV.
Tehran Iran (Islamic Republic of) 1333631151 +98 21 5102 5296 l.simani90@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with vitamin D deficiency (less than 20 ng per ml) Patients with moderate acute stroke based on the NIHSS scoring system 40 years 70 years Both The serum level of vitamin D is above 20 ng per ml Receive antioxidants (such as vitamins C and E) continuously Receive continuous anti-inflammatory drugs (steroids-NSAIDs) AIDS and neurodegenerative diseases (such as Alzheimer's, Parkinson's, ALS, MS Systemic diseases like, Diabetes Mellitus, Kidney Failure, Malignant Melanoma, Uremia, Liver Cirrhosis and Chronic Myocardial Infarction, Myopathy Change in mental status with unknown etiology I63 Cerebral infarction Treatment - Drugs Treatment - Drugs N/A First intervention group: Injection of two vitamins D 3 with a dose of 300,000 units. The first dose is taken after confirmation vitamin D deficiency at the beginning of the disease, and the second dose is one month after the first dose. It used Intramuscular and the drug belongs to the Osweh Pharmaceutical Company. Second intervention group: The patient will receive 6 pearls of vitamin D3 orally at a dose of 50,000 units.The first dose is taken after confirmation of vitamin D deficiency in the patient and next doses are taken weekly after the first dose. The drug belongs to Dana Pharmaceutical Company. Control group: In this group, the drug is not given to the patient and only the level of vitamin D is measured at the beginning and one month later. The level of Tumor necrosis factor alpha. Timepoint: At the beginning of the study (before the intervention), 1 month after the start of taking vitamin D. Method of measurement: Blood sample. The level of Interleukin 6. Timepoint: At the beginning of the study (before the intervention), 1 month after the start of taking vitamin D. Method of measurement: Blood sample. The level of vitamin D. Timepoint: At the beginning of the study (before the intervention), 1 month after the start of taking vitamin D. Method of measurement: Blood Sample. National Institues of Health Stroke Scale Measurement. Timepoint: At the beginning of the study (before the intervention), 1 and 3 months after the start of taking vitamin D. Method of measurement: National Institues of Health Stroke Scale Questionnaire. Measuring Mini Mental State Examination. Timepoint: At the beginning of the study (before the intervention), 1 and 3 months after the start of taking vitamin D. Method of measurement: Mini Mental State Examination Questionnaire. Measuring Modified Rankin Scale. Timepoint: At the beginning of the study (before the intervention), 1 and 3 months after the start of taking vitamin D. Method of measurement: Modified Rankin Scale Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2018-11-12 Ethics Committee of Shahid Beheshti University of Medical Sciences Velenjak St٬ Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)