Increasing the quality of life of chronic obstructive pulmonary disease
Design
Both common treatment groups receive COPD. In addition to the usual treatment, both the case and control groups receive 1000 units of oral Nano D3 capsules daily for 8 weeks.
Settings and conduct
COPD patients have been diagnosed with spirometry using FEV1 and FVC by a pulmonary specialist at Khatam al-Anbia Clinic, and have completed other criteria for entering the study and will enter the study.
Participants/Inclusion and exclusion criteria
Moderate to severe COPD patients
Intervention groups
One group receives vitamin D in addition to the usual COPD treatment, and the other group receives medication.
Main outcome variables
FEV1 و FVC
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190810044500N12
Registration date:2021-05-06, 1400/02/16
Registration timing:registered_while_recruiting
Last update:2021-05-06, 1400/02/16
Update count:0
Registration date
2021-05-06, 1400/02/16
Registrant information
Name
Fatemeh Saghafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
f.saghafi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-11-06, 1400/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effectiveness of vitamin D supplementation in quality of life of patients with chronic obstructive pulmonary disease and vitamin D deficiency
Public title
effectiveness of vitamin D in COPD
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to severe COPD patients
Vitamin D level less than 20ng/ml
age more than 18
Exclusion criteria:
age less than 18 years
Vitamin D level more than 20ng/ml
Mild COPD patients
patients with COPD exacerbation
pregnancy
lactation
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
Blinding description
Blinding has been done on people evaluating variables and data
analysts
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of faculty of medicine, Shahid sadoughi university of medical sciences
Street address
Shahid Sadoughi University of Medical Scienes, Shohada gomnam Blvd, Yazd