Protocol summary

Summary
Objectives : the main aim of this study is the effect of adding 25-hydroxy vitamin D to standard treatment of COPD patients on the improvement of recovery , quality of life and spirometry. Design : this study is double blind randomized clinical tril. Setting and conduct : in this study we register COPD patients referring to a pulmonary subspecialty clinic. Major eligibility criteria : the inclusion of study criteria are as following : the proof of COPD diagnosis according to clinical conditions and its approval with spirometry based on GOLD ; low serum levels of 25-hydroxyvitamin D (10-30) as insufficiency. The study exclusion criteria : hypercalcemia ; ca more than10.3 ; sarcoidosis (according to diagnosis and clinical examination of pulmonary subspecialty) ; cancer(asking the patient) ; osteoprosis that has recently been diagnosed (asking the patient) ; long term use of azithromycin (asking the patient) ; Serum 25-hydroxy vitamin D levels less than 10 as deficiency ; thyroid and parathyroid diseases. Intervention Patients chosen according to inclusion criteria were divided into two groups based on block randomization : one group was under the treatment with vitamin D supplement and another group received placebo , weekly (a tablet with IU 50000 pearl) for 2 months and monthly (a tablet with IU 50000 pearl) for 4 months. Main outcome measures are COPD recovery according to GOLD stage , evaluation of quality of life of patients , serum levels of 25-hydroxyvitamin D. The patients and information collectors are not informed of the study groups. Demographic characteristics of the patients including : age, gender, body mass index , smoking , lung function test and life quality questionnaire (CAT) are recorded in patients’ information forms.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013072114085N2
Registration date: 2014-03-11, 1392/12/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-03-11, 1392/12/20
Registrant information
Name
Ali Alavi
Name of organization / entity
Inflammatory Lung Disease Research Center, Razi Hospital, Gilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3354 2460
Email address
ali_alavi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
1-Vice chancellor of research ,Guilan University of Medical Sciences 2-Pharmaceutical company shafayab
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D on recovery and quality of life of chronic obstructive pulmonary diseasepatients.
Public title
The effect of vitamin D deficiency treatment on chronic obstructive pulmonary diseasepatients
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion of study criteria are as following : the proof of COPD diagnosis according to clinical conditions and its approval with spirometry based on GOLD ; low serum levels of 25-hydroxyvitamin D (10-30) as insufficiency. The study exclusion criteria : hypercalcemia ; ca more than10.3 ; sarcoidosis (according to diagnosis and clinical examination of pulmonary subspecialty ; cancer (asking the patient) ; osteoprosis that has recently been diagnosed (asking the patient) ; long term use of azithromycin (asking the patient) ; serum 25-hydroxy vitamin D levels less than 10 as deficiency ; thyroid and parathyroid diseases.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
patients and the person who collect data are not informed from study groups .

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Council of Guilan University of Medical Sciences
Street address
gaz avenue- shahid beheshti street
City
rasht
Postal code
Approval date
2013-01-01, 1391/10/12
Ethics committee reference number
1910354603

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease

Primary outcomes

1

Description
The rate of change in COPD stage according to GOLD stages
Timepoint
The time of study inclusion and one month later and 6 months later.
Method of measurement
Spirometry

2

Description
Evaluation of quality of life of patients
Timepoint
The time of study inclusion and one month later and 6 months later.
Method of measurement
CAT Questionnair

3

Description
Serum levels of 25-hydroxyvitamin D
Timepoint
The time of study inclusion and one month later and 6 months later.
Method of measurement
Measurement of serum levels of 25-hydroxyvitamin D

Secondary outcomes

1

Description
Mortality
Timepoint
During study
Method of measurement
Recording in patients’ information forms

2

Description
The duration of taking Systemic steroids and antibiotics
Timepoint
During the study
Method of measurement
Recording in patients’ information forms

3

Description
number of exacerbations
Timepoint
duringt study
Method of measurement
recording in patients’ information forms

4

Description
The median time of the occurrence of the first exacerbation during the study
Timepoint
during study
Method of measurement
recording in patients’ information forms

Intervention groups

1

Description
Vitamin D treatment group will take a pill with a dose of 50,000 IU for 2 months and then will take a pill monthly for 4 months.
Category
Treatment - Drugs

2

Description
Placebo treatment group will take a placebo pill for 2 months and then a vitamin D placebo pill monthly for 4 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Pulmonary subspecialty clinic of Dr alavi
Full name of responsible person
Sara Massahnia
Street address
City
rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of research ,Guilan University of Medical Sciences
Full name of responsible person
Dr abdolrasool sobhani
Street address
Gaz square-Vice chancellor of research ,Guilan University of Medical Sciences
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research ,Guilan 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
Respiratory Research Center of Guilan University Medical Sciences
Full name of responsible person
Sara Massahnia
Position
Manager of respiratory research center
Other areas of specialty/work
Street address
Razi hospital -Sardar jangal avenue-Rasht
City
Rasht
Postal code
41448-95655
Phone
+98 13 1554 2460
Fax
+98 13 1554 2460
Email
massahnias@yahoo.com : rrc@gums.ac.ir
Web page address
http://www.gums.ac.ir/rrc

Person responsible for scientific inquiries

Contact
Name of organization / entity
Respiratory Research Center of Guilan University Medical Sciences
Full name of responsible person
Ali Alavi
Position
Pulmonologist
Other areas of specialty/work
Street address
razi hospital--sardar jangal avenue-rasht
City
Rasht
Postal code
41448-95655
Phone
+98 13 1554 2460
Fax
Email
aalavi_foumani@yahoo.comali_alavi@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Respiratory Research Center of Guilan University Medical Sciences
Full name of responsible person
Setare Alavi
Position
Medical student
Other areas of specialty/work
Street address
Sardar jangal avenue-Razi hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1554 2460
Fax
+98 13 1554 2460
Email
rrc@gums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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