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IRCT20200401046909N2 IRCT 2020-04-11 Tehran University of Medical Sciences Evaluation of the efficacy of oral 25-hydroxyvitamin D3 on COVID-19 Investigating preventive effects of oral 25-hydroxyvitamin D3 on COVID-19 in adults: A Randomized, Controlled Double-Blind Clinical Trial. 2020-04-14 anticipated 540 Complete https://irct.ir/trial/47010 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: in this study, the random allocation for intervention and placebo groups is based on a "Random Allocation Software". A simple randomized list will be produced by the software for a sample size of 540 subjects into two groups of the intervention and placebo with equal sample size and numeric sequential unique, Blinding description: It is a double-blind clinical trial. Participants, physicians, data collectors, and project executives are blind to the type of medication (medication and placebo). The drug and placebo are coded by someone else. This person has no role in treatment, data collection and data analysis. The codes are randomly selected for each participant. Each patient has a specific code. Based on the drug coding, the physician or researcher will provide the drug to the participants. medication: containing 25OHD soft gelatin capsular placebo: containing white to off white color suspension oil. 3 COVID-19. Intervention 1: Intervention group: containing 25OHD soft gelatin capsular 1000 IU , Producer: Dishmen. the case group will receive 1000 IUs of 25(OH)D daily for 8 wks. The subjects will receive a bottle containing 30 capsules in first and second visits that will contain the 25(OH)D. The bottles will be returned to be checked at each visit. Intervention 2: Placebo: containing white to off white color suspension oil. Producer: Dishmen Company. The control group will receive placebo daily for 8 wks..The subjects will receive a bottle containing 30 capsules in first and second visits that will contain the placebo. The bottles will be returned to be checked at each visit. Yes - There is a plan to make this available What will be shared: Manuscripts will be published based on the project data When: End of study To whom: For all researchers and clinicians Conditions: Based on the Iran Ministry of Health condition related to clinical trials Where to obtain: Deputy of Research and Technology, Tehran University of Medical Sciences, Tehran, Iran How to obtain: There is no further information. Comments:
public Zhila Maghbooli
Emamkhomeini St., Sina hospital
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6670 6142 zhilayas@gmail.com Tehran University of Medical Sciences scientific Arash Shirvani
02118
Boston United States of America 02118 0016178701376 arash_hs@yahoo.com Boston University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Non-infected with COVID-19 (based on WHO criteria) Older than 17 years old and younger than 76 years old No medications or disorders that would affect vitamin D metabolism Women must be not pregnant at baseline and during study Ability and willingness to give informed consent and comply with protocol requirements 18 years 75 years Both Ongoing treatment with pharmacologic doses of vitamin D, vitamin D metabolites or analogs Pregnant or lactating women Severe underlying diseases, such as an advanced malignant tumor, end-stage lung disease, etc. History of elevated serum calcium levels more than 10.6 mg/dl History of chronic hepatic, renal failure or patients with reduced kidney function, cancers, malabsorption syndrome, or granulomatous disorders such as Sarcoidosis or Tuberculosis Supplementation with over the counter formulations of vitamin D2 or vitamin D3 Use of tanning bed or artificial UV exposure within the last two weeks Consuming medication affecting bone metabolism (anti-convulsants, anti-tuberculosis medication, cimetidine, theophylline, and cholestyramine) Following special diets such as vegetarian diet or consuming fortified products regularly A history of an adverse reaction to orally administered vitamin D, vitamin D metabolites or analogs Inability to give informed consent U07.1 SARS-associated coronavirus as the cause of diseases classified elsewhere Prevention Placebo Intervention group: containing 25OHD soft gelatin capsular 1000 IU , Producer: Dishmen. the case group will receive 1000 IUs of 25(OH)D daily for 8 wks. The subjects will receive a bottle containing 30 capsules in first and second visits that will contain the 25(OH)D. The bottles will be returned to be checked at each visit. Placebo: containing white to off white color suspension oil. Producer: Dishmen Company. The control group will receive placebo daily for 8 wks..The subjects will receive a bottle containing 30 capsules in first and second visits that will contain the placebo. The bottles will be returned to be checked at each visit. Affected by COVID-19. Timepoint: Sign of COVID-19 during study. Method of measurement: patients over 18 years of age with acute respiratory tract infection symptoms (e.g. fever, cough, dyspnea) with no other etiology that fully explains the clinical presentation accompanied by chest computed tomography (CT) scan findings compatible with Covid-19 or definite diagnosis of Covid-19 with real-time polymerase chain reaction (PCR). Infection duration. Timepoint: During study. Method of measurement: WHO criteria. Severity of disease (mild, moderate, sever). Timepoint: During study. Method of measurement: Dyspnea, Palsoximethry result, CBC diff, Blood gas parameters, and acid-base, CT scan result. Serum levels of Vitamin D. Timepoint: Before intervention, end of 4th and end of 8th intervention. Method of measurement: HPLC. Tehran University of Medical Sciences Approved 2020-03-17 Ethics committee of Tehran University of Medical Sciences Research deputy of Tehran University of Medical Sciences, Qods building, Qods St. Cross, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)