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IRCT20190810044500N12 IRCT 2021-05-06 Yazd University of Medical Sciences effectiveness of vitamin D in COPD effectiveness of vitamin D supplementation in quality of life of patients with chronic obstructive pulmonary disease and vitamin D deficiency 2021-05-05 anticipated 60 Complete https://irct.ir/trial/46842 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients were randomly assigned to two groups of 15 controls or intervention by the permutation block method. Treatment assignments within blocks are determined so that they are random in order but that the desired allocation proportions are achieved exactly within each block. 10 blocks of 4 are considered. Generation of random codes using Permuted Block Randomization method will be done with the help of Random allocation software (version 1). The first person who is eligible to enter the study is given number one and likewise, the last eligible person is given number 30. By using the software-generated table, patients receive each intervention (A or B). In order to consider blinding in random allocation, the list is given to another person outside the study and using short message service (SMS) before assigning the type of treatment according to the number of eligible people is asked and thus people enter the study, Blinding description: Blinding has been done on people evaluating variables and data analysts. 2 Chronic obstructive pulmonary disease. Intervention 1: Intervention group: Receive 1000 IU of Vitamin D3 capsule daily for 8 weeks. Intervention 2: Control group: Receive placebo of oral Vitamin D3 1000 capsule daily for 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is no more information
public Fatemeh Saghafi
Shahid Sadoughi University of Medical Sciences., Profossor Hesabi Blvd., Yazd
Yazd Iran (Islamic Republic of) 89151731498 +98 35 3820 3419 f.saghafi@ssu.ac.ir Yazd University of Medical Sciences scientific Fatemeh saghafi
Yazd
Yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3419 f.saghafi@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Moderate to severe COPD patients Vitamin D level less than 20ng/ml age more than 18 18 years no limit Both age less than 18 years Vitamin D level more than 20ng/ml Mild COPD patients patients with COPD exacerbation pregnancy lactation J44.9 Chronic obstructive pulmonary disease, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Receive 1000 IU of Vitamin D3 capsule daily for 8 weeks Control group: Receive placebo of oral Vitamin D3 1000 capsule daily for 8 weeks Percentage of people with chronic obstructive pulmonary disease. Timepoint: Before the start of the intervention and in the 2nd and 4th month of the start of treatment and after the end of treatment. Method of measurement: Blood sample. Quality of Life. Timepoint: Before the start of the intervention and in the 2nd and 4th month of the start of treatment and after the end of treatment. Method of measurement: questionnaire ( EORTC QLQ - C30 version 3). Yazd University of Medical Sciences Approved 2020-11-10 Ethics Committee of faculty of medicine, Shahid sadoughi university of medical sciences Shahid Sadoughi University of Medical Scienes, Shohada gomnam Blvd, Yazd Yazd Yazd Iran (Islamic Republic of)