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IRCT20210327050775N1 IRCT 2021-05-25 Islamic Azad University Effect of vitamin D on the prognosis of patients with COVID-19 Investigating the status of vitamin D and its complementary effect on the prognosis of patients with COVID-19 bedridden in Hospital 2021-05-22 anticipated 120 Complete https://irct.ir/trial/55405 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants, lead researcher, Treatment staff (Physicians, Nurses), Data collector, Outcome assessor and data analyzer will not know the level of the disease and the type of drug (vitamin D or placebo) and the amount of vitamin D injected. In the end of the research will be communicated to the participants. 3 Covid-19. Intervention 1: Intervention group 1: Patients with Mild level of Covid-19 with vitamin D deficiency (less than 30 ng /ml). Intervention by taking routine medications in addition Consumption of vitamin D in the form of calciferol 300,000 units. Number of uses: Once and at the time of hospitalization of the patient, How to use: Injection into the gluteus muscle, Manufacturer: Tehran Daroo Company. Intervention 2: Intervention group 2: Patients with Severe level of Covid-19 with vitamin D deficiency (less than 30 ng /ml). Intervention by taking routine medications in addition Consumption of vitamin D in the form of calciferol 300,000 units. Number of uses: Once and at the time of hospitalization of the patient, How to use: Injection into the gluteus muscle, Manufacturer: Tehran Daroo Company. Intervention 3: Intervention group 3: Patients with Very severe level of Covid-19 with vitamin D deficiency (less than 30 ng /ml). Intervention by taking routine medications in addition Consumption of vitamin D in the form of calciferol 300,000 units. Number of uses: Once and at the time of hospitalization of the patient, How to use: Injection into the gluteus muscle, Manufacturer: Tehran Daroo Company. Intervention 4: Control group 1: Patients with mild level of Covid-19 with vitamin D deficiency (more than 30 ng/ml). Intervention by taking routine medications in addition Consumption of placebo(Distilled water). Number of uses: Once and at the time of hospitalization of the patient, How to use: Injection into the gluteus muscle. Intervention 5: Control group 2: Patients with severe level of Covid-19 with vitamin D deficiency (more than 30 ng/ml). Intervention by taking routine medications in addition Consumption of placebo(Distilled water). Number of uses: Once and at the time of hospitalization of the patient, How to use: Injection into the gluteus muscle. Intervention 6: Control group: Patients with very severe level of Covid-19 with vitamin D deficiency (more than 30 ng/ml). Intervention by taking routine medications in addition Consumption of placebo(Distilled water). Number of uses: Once and at the time of hospitalization of the patient, How to use: Injection into the gluteus muscle. Yes - There is a plan to make this available What will be shared: In participants' individual data: Part of the data such as information about the main outcome In the study protocol: the whole method of conducting research In the statistical analysis map: statistical tests used In the form of informed consent: Only the raw form to make the participants unrecognizable When: Access period starts 3 months after the results are published To whom: Researchers working in academic, scientific and private institutions Conditions: Research use in similar cases by providing research approval code from university centers Where to obtain: By E-mail to the address: Nikkhah_somayeh@yahoo.com With Somayeh Nikkhah How to obtain: After receiving the request email and also submitting the research approval code, the documents will be emailed within a week. Comments:
public Somayeh Nikkhah
No. 23, Abnoos 7 Ave
Kerman Iran (Islamic Republic of) 7619658464 +98 34 3243 8239 Nikkhah_somayeh@yahoo.com Islamic Azad University scientific Somayeh Nikkhah
No. 23, Abnoos 7 Ave
Kerman Iran (Islamic Republic of) 7619658464 +98 34 3243 8239 Nikkhah_somayeh@yahoo.com Islamic Azad University Iran (Islamic Republic of) Being aged 20-70 years Hospitalization Positive polymerase chain reaction test (RT-PCR) No pre-existing already pneumonia, Chronic obstructive pulmonary diseas(COPD) and other respiratory illnesses No known chronic diseases (diabetes, hypertension, underlying heart disease, infectious, liver, kidney and epilepsy, neuromuscular, immune deficiency diseases and cancer) Not being hospitalized in the past month Do not have stressors such as the death of first-degree relatives, etc. in a recent month Not pregnant Do not use oral contraceptives, vitamin products, calcium, anticonvulsants, estrogen and diuretics Do not take injectable vitamin D in the last 6 months Lack of seasonal sensitivity 20 years 70 years Both Dissatisfaction or obedience to the treatment to continue participating in the study Diagnosis of chronic diseases at the time of hospitalization U07.02 COVID-19 Disease Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Patients with Mild level of Covid-19 with vitamin D deficiency (less than 30 ng /ml). Intervention by taking routine medications in addition Consumption of vitamin D in the form of calciferol 300,000 units. Number of uses: Once and at the time of hospitalization of the patient, How to use: Injection into the gluteus muscle, Manufacturer: Tehran Daroo Company. Intervention group 2: Patients with Severe level of Covid-19 with vitamin D deficiency (less than 30 ng /ml). Intervention by taking routine medications in addition Consumption of vitamin D in the form of calciferol 300,000 units. Number of uses: Once and at the time of hospitalization of the patient, How to use: Injection into the gluteus muscle, Manufacturer: Tehran Daroo Company. Intervention group 3: Patients with Very severe level of Covid-19 with vitamin D deficiency (less than 30 ng /ml). Intervention by taking routine medications in addition Consumption of vitamin D in the form of calciferol 300,000 units. Number of uses: Once and at the time of hospitalization of the patient, How to use: Injection into the gluteus muscle, Manufacturer: Tehran Daroo Company. Control group 1: Patients with mild level of Covid-19 with vitamin D deficiency (more than 30 ng/ml). Intervention by taking routine medications in addition Consumption of placebo(Distilled water). Number of uses: Once and at the time of hospitalization of the patient, How to use: Injection into the gluteus muscle. Control group 2: Patients with severe level of Covid-19 with vitamin D deficiency (more than 30 ng/ml). Intervention by taking routine medications in addition Consumption of placebo(Distilled water). Number of uses: Once and at the time of hospitalization of the patient, How to use: Injection into the gluteus muscle. Control group: Patients with very severe level of Covid-19 with vitamin D deficiency (more than 30 ng/ml). Intervention by taking routine medications in addition Consumption of placebo(Distilled water). Number of uses: Once and at the time of hospitalization of the patient, How to use: Injection into the gluteus muscle. Pregnosis and severity disease in patients with Covid 19. Timepoint: Determination of prognosis and severity disease in the beginning of the study (before the intervention) and 7, 14 days after the start of vitamin D intake. Method of measurement: Guidelines issued by the National Health Commission for the diagnosis and treatment of coronavirus. Islamic Azad University Approved 2020-10-13 Ethics Committee of Islamic Azad Tehran Medical Sciences University No. 23, Abnoos 7., Abnoos 7 Ave Kerman Kerman Iran (Islamic Republic of)