Effectiveness of Vitamin D Supplementation in Quality of Life of patient with severe and very severe Chronic Obstructive Pulmonary Disease with serum levels of Vitamin D less than 20ng/ml compared with the control group
The main aim of current study is to define the effectiveness of vitamin D supplement in quality of life of patients with severe and very severe chronic obstructive pulmonary disease with Vitamin D Deficiency. A randomized double blind clinical trial that will be randomized in two groups (intervention and control) based on blocked randomization. In this study 84 patients will participate. The intervention group (42 patients) will receive vitamin D and the control group (42 patients) will receive placebo. Neither patients nor their physicians will know in which group the patients are. The inclusion criteria of the study are as the following: Patients with vitamin level less than 20 nano gram per milliliter;age more than 40. The study exclusion criteria: Patients who receive vitamin d supplementation more than 400 unit per day ;Taking daily dose of systemic corticosterioid( oral or injection) as maintenance. the Intervention group will receive vitamin D3 as an oral pearl (50,000 IU) weekly for 8 weeks and then they will continue the treatment every two weeks for 4 months. In the control group, patients will receive placebo on the same time schedule. The primary outcome is to improve the quality of life which measures by SGRQ-C, m-MRC, and CAT, first exacerbation of COPD, and serum level of vitamin D3.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021030705N1
Registration date:2017-02-10, 1395/11/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Boyuk Moradkhani
Name of organization / entity
North Khorasan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 58 3222 7032
Email address
b.moradkhani@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
North Khorasan University of Medical Sciences, Bojnourd, Iran
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
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 patient with severe and very severe Chronic Obstructive Pulmonary Disease with serum levels of Vitamin D less than 20ng/ml compared with the control group
Public title
Vitamin D efficacy on COPD
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients with vitamin level more than 20 nano gram per milli liter; age more than 40;patients with diagnosis of severe and very severe COPD; patients who complete the consent form Exclusion criteria: Patient who receive vitamin D supplementation more than 400 unit per day; taking daily dose of systemic corticosteroid(oral or ingection) as maintenance; personal history of one of the following diseases: Osteoporosis, Asthma, renal failure, liver failure, Nephrolithiasis, Hypercalcemia, active TB, Malignancy, Sarcoidosis, Malabsorption; pregnancy and lactation or individuals who want to be pregnant during the study; using of antileptic drugs(barbitorat and phenytoin,) and alcohol; patient with psychological problem; unreliable patients in study.
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of North Khorasan University of Medical Science
At time of inclusion, 1, 3, and 6 months after treatment
Method of measurement
m-MRC Questionnaire
2
Description
The time of first acute exacerbation
Timepoint
During the study
Method of measurement
Recording in the patients’ information form
3
Description
Evaluation of quality of life
Timepoint
At time of inclusion, 1, 3, and 6 months after treatment
Method of measurement
SGQR-C Questionnaire
4
Description
Evaluation of quality of life
Timepoint
At time of inclusion, 1, 3, and 6 months after treatment
Method of measurement
CAT Questionnaire
Secondary outcomes
1
Description
The number of hospitalization
Timepoint
During the study
Method of measurement
Recording in the patients’ information form
2
Description
Length of stay
Timepoint
During the study
Method of measurement
Recording in the patients’ information form
3
Description
Serum level of 25-hydroxyvitamin D
Timepoint
At time of inclusion, 1, 3, and 6 months after treatment
Method of measurement
Measurement of serum level
Intervention groups
1
Description
Intervention group: Patients in this group will take oral pearl Vitamin D3 (50,000 IU) weekly for 8 weeks. Then, They receive this dose of Vitamin D3 every two weeks for 4 months (Totally 16 doses).
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will take a placebo exactly the same as the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
North Khorasan University of Medical Sciences
Full name of responsible person
Street address
City
Bojnourd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Alireza Golshan
Street address
No36,Shahid Mohaghar sreet, Shahid Beheshti Avenue, boujnourd. North Khorasan,Iran
City
Bojnourd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
North Khorasan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Internal Medicine, North Khorasan University of Medical Sciences
Full name of responsible person
Mohammad Bagher Oghazian
Position
Assistant Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
North Khorasan University of Medical Sciences .Shahriar street, Bojnourd, North Khorasan, Iran
City
Bojnourd
Postal code
Phone
+98 58 3224 0086
Fax
Email
s_oghazian@live.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Boyuk Morad-Khani
Position
Assistant Professor of Medicine. Fellowship in Adult Pulmonary
Other areas of specialty/work
Street address
North Khorasan University of Medical Sciences .Shahriar street
City
Bojnourd
Postal code
Phone
+98 58 3229 6764
Fax
Email
b.moradkhani@nkums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Habibeh Sadat Shakeri
Position
Assistant professor of Medicine, Fellowship in Endocrinology & Metabolism
Other areas of specialty/work
Street address
North Khorasan University of Medical Sciences .Shahriar street
City
Bojnourd
Postal code
Phone
00
Fax
Email
drhssh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)