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IRCT20090909002438N4 IRCT 2022-10-11 Guilan University of Medical Sciences "Evaluation of the Effect of Vitamin D Supplementation on the Recovery of Children Suffering from Coronavirus Disease 2019" Evaluation of the Effect of Vitamin D Supplementation on the Recovery of Hospitalization Children Suffering from Coronavirus Disease 2019 in Hospital 2022-09-23 anticipated 40 Complete https://irct.ir/trial/64355 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is random block allocation, and patients will be randomly divided into two groups, including intervention with vitamin D and the control group with placebo. The randomization unit is individual and people will be selected individually. Randomization will be done in the form of sealed opaque envelopes with a random sequence. At first, each of the randomly generated sequences is recorded on a card. Then, the cards are placed in the envelopes in order. In order to maintain the random sequence, the outer surface of the numbered envelopes is placed in the same order. After that, the lid of the envelopes is glued and they are placed in the box in order. The randomization tool is online software (www.sealed envelope.com). First, registration is done on the site. The number of blocks is 5 and 8 people are selected in each block. According to the required sample size and block size, a randomization list of people to be placed in treatment groups is produced. At the time of registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: Drug concealment was also performed using opaque envelopes sealed in random sequence, opaque envelopes, sealed, numbered respectively. Each random sequence created is recorded on a card and the cards are placed in the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of the participants, one of the envelopes of the letter is opened in order and the assigned group of that participant is revealed. The coding is done by one of the project partners and the evaluating physician and the patient are blind. N/A Coronavirus Disease 2019. Intervention 1: Intervention group: Hospitalized children with COVID-19 are 3 months to 14 years old and will receive daily vitamin D with a dose of 1000 international units. Intervention 2: Control group: Hospitalized children with COVID-19 are 3 months to 14 years old and will receive a daily Placebo made by Barij Essence Company. Yes - There is a plan to make this available What will be shared: All documents or patient data files will be provided to the Vice Chancellor for Research and Treatment. The results of the study will be published in the form of an article resulting from the project without mentioning the names of the participants. When: The access period is 6 months after the publication of results in the form of an article. To whom: The results of the research will be available to all researchers as a published article. Conditions: Researchers will send a written request to executor of the project stating the reasons and details for accessing the data and documentation. After review by the ethics committee and the research council, if approved, will be sent. Where to obtain: Researchers will send a written request to executor of the project stating the reasons and details for accessing the data and documentation. How to obtain: Researchers will send a written request to executor of the project stating the reasons and details for accessing the data and documentation. After review by the ethics committee and the research council, if approved, will be sent. Comments: The applicant must also state in full detail the reason for his / her need for data and documentation.
public Houman Hashemian
Parastar Ave., Farhang Square., Rasht Town, Iran
Rasht Iran (Islamic Republic of) 41937-13111 +98 13 3334 6489 hashemian@gums.ac.ir Guilan University of Medical Sciences scientific Houman Hashemian
Parastar Ave., Farhang Square., Rasht Town, Iran
Rasht Iran (Islamic Republic of) 41937-13111 +98 13 3334 6489 hashemian@gums.ac.ir Guilan University of Medical Sciences Iran (Islamic Republic of) Children suffering from coronavirus disease 2019 (COVID-19) 3 months to 14 years old hospitalization children in hospital 3 months 14 years Both Children that have a history of hepatitis disease Children that have malabsorption disorder Children that are undergoing chemotherapy U07.1 COVID-19, virus identified Treatment - Other Placebo Intervention group: Hospitalized children with COVID-19 are 3 months to 14 years old and will receive daily vitamin D with a dose of 1000 international units Control group: Hospitalized children with COVID-19 are 3 months to 14 years old and will receive a daily Placebo made by Barij Essence Company. The effect of vitamin D consumption on the fever. Timepoint: Assess the severity of the Coronavirus disease 2019 at the beginning of the study (before the intervention) and every 24 hours after starting cunsumtion of vitamin D as daily. Method of measurement: Mercury thermometer device. The effect of vitamin D consumption on the respiratory distress. Timepoint: Assess the severity of the Coronavirus disease 2019 at the beginning of the study (before the intervention) and every 24 hours after starting consumption of vitamin D as daily. Method of measurement: Pulse oximeter device. The effect of vitamin D consumption on hospitalization. Timepoint: Assess the severity of the Coronavirus disease 2019 at the beginning of the study (before the intervention) and every 24 hours after starting consumption of vitamin D as daily. Method of measurement: Number of days of hospitalization for treatment. Guilan University of Medical Sciences Approved 2022-06-01 Ethics committee of Guilan University of Medical Sciences Parastar Ave., Farhang Square., Rasht Town, Iran Rasht Guilan Iran (Islamic Republic of)