Protocol summary

Summary
The aim of this sudy was to evaluation of vitamin D supplementation on pulmonary functions of chronic obstructive pulminary disease patients.Inclusion criteria consist of current or ex-smokers or who were exposed to noxious inhalents, had a diagnosis of chronic obstructive pulminary disease according to the global initiative for chronic obstructive lung disease definition, had no history of exacerbationchronic of obstructive pulminary disease one year before study, no history of renal stone or renal failure or other diseases that interact with vitamin D metabolism or were not taking vitamin D or calcium supplements, no continuse need to oxygen therapy or during exercise.Exclusion characteria include noncompliance, exacerbation of chronic obstructive pulminary disease during study. This study was a before and after that was performed on 23 outpatients with chronic obstructive pulmonary disease according to the global initiative for chronic obstructive lung disease definition. At the begining of the study, baseline characteristics included serum level of 25(OH) vitamin D through ELISA method. The patients were given 3000000 IU of vitamin D for insufficient(30 ng/ml) and 600000 IU for defficient(20 ng/ml) level of vitamin D as loading dose.Treatment was continued with 50000 IU vit D per oral as pearl weekly for 12 weeks. Primary outcomes were correction of forced expiratory volume in first second.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015012720828N1
Registration date: 2015-06-09, 1394/03/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-09, 1394/03/19
Registrant information
Name
Maryam Haddadzadeh Shoushtari
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 1839
Email address
haddadzadeh-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
1-Vice chancellery for Development, Research and Technology of of Iran University of medical Sciences. 2-Researcher
Expected recruitment start date
2011-01-31, 1389/11/11
Expected recruitment end date
2014-06-30, 1393/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efiicacy of vitamin D supplementation on pulmonary function tests of chronic obstructive pulmonary disease
Public title
Efiicacy of vitamin D on chronic lung disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who were current or ex-smokers or were exposed to noxious inhalents; had a diagnosis of chronic obstructive pulmonary disease according to the gobal initiative for chronic obstructive lung Disease definition; had no history of chronic obstructive pulmonary disease exacerbation one year before study; no history of renal stone or renal failure or other diseases that interact with vitamin D metabolism or were not taking vitamin D or calcium supplements ; no continuse need to oxygen therapy or during exercise. Exclusion characteria: noncompliance; exacerbation of chronic obstructive pulmonary disese during study.
Age
From 14 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 23
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
iran university of medical sciences
Street address
hemmat highway
City
tehran
Postal code
141555983
Approval date
2014-08-30, 1393/06/08
Ethics committee reference number
1213/105/ص/93

Health conditions studied

1

Description of health condition studied
chronic obstructive airway diseases
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
Forced expiratory volume in one second
Timepoint
before intervention and three month later at the end of study
Method of measurement
percent of predicted

Secondary outcomes

1

Description
saturation of oxygen and six minutes walk test
Timepoint
before intervention and three months after intervention
Method of measurement
percent and meters

2

Description
saturation of oxygen and six minutes walk test
Timepoint
before intervention and three month later at the end of the study
Method of measurement
percent and meter

Intervention groups

1

Description
3000000-600000 IU of vitamin D as loading dose and 50000 IU weekly for three month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomaini hospital
Full name of responsible person
Maryam Haddadzadeh Shoushtari
Street address
Azadegan street
City
Ahvaz

2

Recruitment center
Name of recruitment center
Hazrat Rassol Hospital
Full name of responsible person
maryam Haddadzadeh Shoushtari
Street address
nyaiesh street, satarkhan street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellery for Development, Research and Technology of of Iran University of medical Sciences
Full name of responsible person
dr. Seied Ali Javad Moosavi
Street address
Hemmat heighway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for Development, Research and Technology of of Iran 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
Ahvaz jundishapour university of medical sciences
Full name of responsible person
Maryam haddadzadeh Shoushtari
Position
Pulmonologist/Head of medical ethic department
Other areas of specialty/work
Street address
Imam Khomaini hospital, Azadegan street
City
Ahvaz
Postal code
Phone
+98 61 3292 1839
Fax
Email
haddadzadeh-m@ajums.ac.irm.haddadzadeh_sh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapour of medical sciences
Full name of responsible person
Maryam haddadzadeh Shoushtari
Position
Pulmonologist
Other areas of specialty/work
Street address
Azadegan street
City
Ahvaz
Postal code
Phone
+98 61 3292 1839
Fax
Email
haddadzadeh-m@ajums.ac.irm.haddadzadeh_sh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz jundishapour university of medical sciences
Full name of responsible person
Maryam Haddadzadeh Shoushtari
Position
Pulmonologist/Head of the medical ethic department
Other areas of specialty/work
Street address
Azadegan street
City
Ahvaz
Postal code
Phone
+98 61 3292 1839
Fax
Email
m-haddadzadeh-m@ajums.ac.irm.haddadzadeh_sh@yahoo.com
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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