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IRCT20200401046909N1 IRCT 2020-04-09 Tehran University of Medical Sciences Evaluation of the efficacy of oral 25-hydroxyvitamin D3 on COVID-19 The efficacy of oral 25-hydroxyvitamin D3 on COVID-19 treatment in adults: A Randomized, Controlled Double-Blind Clinical Trial. 2020-04-15 anticipated 260 Complete https://irct.ir/trial/46875 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial, 260 patients with positive COVID-19 will be recruited. Patients will be randomly allocated to the drug group (N=130) and placebo group (N=130). The randomization method is "restricted randomization". It will be determined by a "Random Allocation Software". Subjects in the drug group will receive 1000 IUs of 25(OH)D daily for 8 wks and subjects in the placebo group will receive placebo daily for 8 wks, Blinding description: 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: the primary outcome measures When: six months after publishing paper/ until 2 years after the end of the study To whom: Based on the Iran Ministry of a health condition related to clinical trials Conditions: Based on Iran Ministry of Health condition related to clinical trials Where to obtain: the email address of the principal investigator How to obtain: The request will be reviewed by the project executors and then Deputy of Research and Technology, Tehran University of Medical Sciences, Tehran, Iran. 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) Iran (Islamic Republic of) 2019-nCov (SARA-Cov-2) nucleic acid positive will be detected by PCR in affected patients 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 analogues Pregnant or lactating women; Severe underlying diseases, such as advanced malignant tumor, end-stage lung disease, etc. History of elevated serum calcium >9.8 mg/dl) Chronic hepatic or renal failure or patients with reduced kidney function, cancers, and malabsorption syndrome, a 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), as well as those who are following special diets such as vegetarian diet or consuming fortified products regularly. Subjects with a history of an adverse reaction to orally administered vitamin D, vitamin D metabolites or analogues. Inability to give informed consent U07.1 SARS-associated coronavirus as the cause of diseases classified elsewhere Prevention Treatment - Drugs 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. 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 method. 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)