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IRCT20200729048247N1 IRCT 2020-09-14 Kashan University of Medical Sciences Effect of Vitamin D in Rhinosinusitis with Nasal Polyps Effect of oral Vitamin D Supplementation in recovery of the Patients with Chronic Rhinosinusitis with Nasal Polyps and Vitamin D insufficiency 2020-08-03 anticipated 72 Complete https://irct.ir/trial/49985 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method was done by permuted blocked randomization first quadrople random block (a.b) was made. Then it was selected by using random number table of a.b letters(72) and based on the entrance number of patient to the study with the prepared random trail one of the a or b letter was excluded. Random sample was selected using <randomizer.ir> website, Blinding description: In performing this intervention participants and outcome assessors and physician were all unaware of the type of medication the patient was taking. pills presented with exact similar size and color and packing and specific code that was allocated before with random number table. 3 Nasal polyps / Chronic rhinosinusitis. Intervention 1: Intervention group: treatment of vitamin D insufficiency with pearl 50000 u vitamin D per week until 8 weeks per oral(Produced by Zahravi Company). Intervention 2: Control group: placebo prescribed(With pearls of the same color, size and shape of vitamin D pearls) per week until 8 weeks per oral(Produced by Zahravi Company). Yes - There is a plan to make this available What will be shared: Any detail going to published When: starting 2 months after publication To whom: Any scientific and collegiate institutions Conditions: Any analusis allowed Where to obtain: leilakln284@gmail.com Leila kalantari How to obtain: About 1 month after request with email Comments:
public Leila Kalantari
Kashan University of Medical Sciences, Qotb Ravandi Blvd,Kashan Town
Isfahan Iran (Islamic Republic of) 8715973474 +98 31 5545 1421 Kalantari-l@kaums.ac.ir Kashan University of Medical Sciences scientific Leila Kalantari
Kashan University of Medical Sciences, Qotb Ravandi Blvd,Kashan Town
Isfehan Iran (Islamic Republic of) 8715973474 +98 31 5545 1421 Leilakln284@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Chronic rhinosinusitis diagnosed Existence of nasal polyps on examination Vitamin D insufficiency documented in laboratory findings Conscious consent to study 10 years no limit Both Use of systemic corticosteroids or other immunosuppressive drugs pregnancy Age less than 10 years Existence of immunological, renal, digestive, glandular and musculoskeletal disorders such as rheumatoid arthritis, immunodeficiency, cystic fibrosis, ciliary dyskinesia, malabsorption J33 Nasal polyp / Chronic rhinosinusitis / vitamin D Treatment - Drugs Placebo Intervention group: treatment of vitamin D insufficiency with pearl 50000 u vitamin D per week until 8 weeks per oral(Produced by Zahravi Company) Control group: placebo prescribed(With pearls of the same color, size and shape of vitamin D pearls) per week until 8 weeks per oral(Produced by Zahravi Company) Improvement of disease grade. Timepoint: Before starting the intervention and 8 weeks later. Method of measurement: Endoscopy before starting study and 8 weeks after starting treatment protocol. Serum level of vitamin D. Timepoint: Measurment of serum level of vitamin D at baseline and 8 weeks after the intervention. Method of measurement: Vitamin D blood test. Headache Improvement. Timepoint: Before starting the intervention and 8 weeks later. Method of measurement: Visual analogue scale. Improvement of facial pain. Timepoint: Before starting the intervention and 8 weeks later. Method of measurement: Visual analogue scale. Improvement of hyposmia. Timepoint: Before starting the intervention and 8 weeks later. Method of measurement: Visual analogue scale. Decreasing of post nasal drip. Timepoint: Before starting the intervention and 8 weeks later. Method of measurement: Visual analogue scale. Decreasing of rhinorrhea. Timepoint: Before starting the intervention and 8 weeks later. Method of measurement: Visual analogue scale. Improvement of Nasal obstruction. Timepoint: Before starting the intervention and 8 weeks later. Method of measurement: Visual analogue scale. Improvement of congestion. Timepoint: Before starting the intervention and 8 weeks later. Method of measurement: Visual analogue scale. Improvement of fever. Timepoint: Before starting the intervention and 8 weeks later. Method of measurement: Visual analogue scale. Improvement of Halitosis. Timepoint: Before starting the intervention and 8 weeks later. Method of measurement: Visual analogue scale. Improvement of Drought. Timepoint: Before starting the intervention and 8 weeks later. Method of measurement: Visual analogue scale. Improvement of cough. Timepoint: Before starting the intervention and 8 weeks later. Method of measurement: Visual analogue scale. Improvement of ear pain. Timepoint: Before starting the intervention and 8 weeks later. Method of measurement: Visual analogue scale. Kashan University of Medical Sciences Approved 2020-08-03 Ethics committee of kashan University of Medical Sciences Kashan University of Medical Sciences، ghotb ravandi blvd، kashan town Kashan Isfehan Iran (Islamic Republic of)