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IRCT20200825048515N10 IRCT 2020-10-24 Esfahan University of Medical Sciences The Effect of Vitamin D Supplementation on Improvement of Symptoms in Asthma Patients with Vitamin D Insufficiency and Deficiency The Effect of Vitamin D Supplementation on Improvement of Symptoms in Mild-to-Moderate Asthma Patients with Vitamin D Insufficiency and Deficiency 2015-08-23 anticipated 132 Complete https://irct.ir/trial/51638 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 66 patients with asthma and vitamin D deficiency and also 66 patients with asthma and insufficient levels of vitamin D will be selected using simple randomization. These two groups of 66 people are then coded with the aid of random allocation software and are automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly studied in one of the two groups, Blinding description: To blind the study, vitamin D and placebo will be prepared in the same shape and color by the pharmacist before the intervention. These drugs will then be coded and made available to the researcher. They also prescribe them without knowing the type of any of the drugs. Also, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 3 Asthma. Intervention 1: Control group: Patients with asthma and vitamin D deficiency, in addition to receiving conventional asthma control medications (SymbiCort inhalation spray), received placebo for 6 weeks. Intervention 2: Control group: Patients with asthma and insufficient levels of vitamin D, in addition to receiving commonly used asthma control drugs (SymbiCort inhalation spray), received placebo for 6 weeks. Intervention 3: Intervention group: Patients with asthma and vitamin D deficiency, in addition to taking the usual asthma control medications (SymbiCort inhalation spray), take a 50,000-unit vitamin supplement orally every week for up to 6 weeks until the serum level of vitamin D reaches more than 20 ng/ml, then they will be prescribed 1000 units daily. Intervention 4: Intervention group: Patients with asthma and inadequate vitamin D level, in addition to taking the usual asthma control medications (SymbiCort inhalation spray), will be prescribed 1000 unit vitamin supplement orally daily for 4 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mohammad Emami Ardestani
Lung Clinic, Al-Zahra Hospital, Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 m_emamiardestani@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Emami Ardestani
Lung Clinic, Al-Zahra Hospital, Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 m_emamiardestani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with mild-to-moderate asthma Patients with vitamin D insufficiency and deficiency Being consent to participate in the study 18 years no limit Both Diagnosis of chronic obstructive pulmonary disease (COPD) Sarcoidosis Hyperthyroidism Kidney stones Active tuberculosis Vitamin D intolerance Liver failure Kidney failure Suffering from lymphomas or other malignant tumors that have not healed in more than two years of treatment Treatment with anticonvulsant drugs, vitamin D supplements Treatment with systemic corticosteroids for more than 3 months prior to study Breastfeeding or pregnancy a basal serum calcium concentration of >2.65 mmol / L Exacerbation of asthma in the three months before the study Active or inactive smoking J45 Asthma Placebo Placebo Treatment - Drugs Treatment - Drugs Control group: Patients with asthma and vitamin D deficiency, in addition to receiving conventional asthma control medications (SymbiCort inhalation spray), received placebo for 6 weeks. Control group: Patients with asthma and insufficient levels of vitamin D, in addition to receiving commonly used asthma control drugs (SymbiCort inhalation spray), received placebo for 6 weeks. Intervention group: Patients with asthma and vitamin D deficiency, in addition to taking the usual asthma control medications (SymbiCort inhalation spray), take a 50,000-unit vitamin supplement orally every week for up to 6 weeks until the serum level of vitamin D reaches more than 20 ng/ml, then they will be prescribed 1000 units daily. Intervention group: Patients with asthma and inadequate vitamin D level, in addition to taking the usual asthma control medications (SymbiCort inhalation spray), will be prescribed 1000 unit vitamin supplement orally daily for 4 weeks. Control of asthma symptoms. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Asthma Control Test (ACT score). FEV1 parameter. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Spirometer device. FVCparameter. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Spirometer device. Serum vitamin D level. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Radioimmunoassay method. Isfahan University of Medical Sciences Approved 2016-10-10 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)