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Evaluation of Effects Oral Supplements Vitamine D on COPD Exacerbation and FEV1 in Patients With Severe and Very Severe COPD

Protocol summary

Summary
randomised/double blind/case-control/control without pelacebo Inclusion criteria:choronic obstructive pulmonary diseases patients with FEV1/FVC<0/7 and FEV1<50%;negative past medical history of vitamines D disorders exclusion criteria:positive past medical history of vitamine D disorders target sample size:88 patients in case group have intervated with oral agents vitamineD(in 6 months with doses100000internationalunits of vitamine D3 monthly within 6months)and routin drugthrapy for choronic obstructive pulmonary diseases .patients in control group have treatment wiyh routin drugs for choronic obstructive pulmonary diseases. duration of intervention:1390/12/15-1391/07/15

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012071810332N1
Registration date: 2012-08-07, 1391/05/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-08-07, 1391/05/17
Registrant information
Name
Elham Senisel bachari
Name of organization / entity
Khorramabadmedical university
Country
Iran (Islamic Republic of)
Phone
+98 916 333 3143
Email address
eli2shim@yahoo.com
Recruitment status
Recruitment complete
Funding source
Khorramabad University Of Medical Sciences
Expected recruitment start date
2012-03-05, 1390/12/15
Expected recruitment end date
2012-10-06, 1391/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effects Oral Supplements Vitamine D on COPD Exacerbation and FEV1 in Patients With Severe and Very Severe COPD
Public title
Effects Oral Agents Vitamine D On COPD
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusioncriteria:COPD patients with FEV1/FVC<0/7 and FEV1<50%;negative past medical history of vitamines D disorders exclusion criteria:positive past medical history of vitamine D disorders
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Khorramabad University Of Medical Sciences
Street address
Pardis departmen، Kamalvand region، Khorramabad، Lorestan
City
Khorramabad
Postal code
Approval date
2012-06-10, 1391/03/21
Ethics committee reference number
1280

Health conditions studied

1

Description of health condition studied
Severe and very severe COPD
ICD-10 code
j44
ICD-10 code description
Chronic obstructive pulmonary diseases

2

Description of health condition studied
Added at 2012-08-07: chronic obstructive pulmonary diseases
ICD-10 code
Added at 2
ICD-10 code description
Added at 2012-08-07:

Primary outcomes

1

Description
FEV1
Timepoint
Before intervention and after intervention
Method of measurement
Spirometery(PFT)

Secondary outcomes

1

Description
COPD Exacerbation
Timepoint
Before and mean and afterof intervention
Method of measurement
Physical exam

Intervention groups

1

Description
patients in case group have intervened with oral agents vitamineD(in 6 months with doses100000internationalunits of vitamin D3 monthly within 6months)and routin drugthrapy for Chronic obstructive pulmonary diseases.patients
Category
Prevention

2

Description
in control group have treatment with routine drugs for Chronic obstructive pulmonary diseases
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorramabad Shohadaye Ashayer Hospital
Full name of responsible person
Street address
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khorramabad Univercity Of Medical Sciences
Full name of responsible person
Doktor Qolamreza Kayedi
Street address
Pardis department، Kamalvand region، Khorramabad، Lorestan
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khorramabad Univercity 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
Khorramabad Univercity Of Medical Sciences
Full name of responsible person
Doktor Abolphazl Zendedel
Position
Chief of Khorramabad Univercity Of Medical Sciences
Other areas of specialty/work
Street address
Pardis department، Kamalvand region، Khorramabad، Lorestan
City
Khorramabad
Postal code
Phone
+98 66 1620 0133
Fax
Email
www.a.zendedel@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khorramabad University Of Medical Sciences
Full name of responsible person
Doktor Abolphazl Zendedel
Position
chief of khorramabad University Of Medical Sciences
Other areas of specialty/work
Street address
Pardis department، Kamalvand region، KhorramAbad، lorestan
City
Khorramabad
Postal code
Phone
+98 66 1620 0133
Fax
Email
www.a.zendedel@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Khorramabad University Of Medical Sciences
Full name of responsible person
Doktor Abolphazl Zendedel
Position
Chief of Khorramabad Univercity Of Medical Sciences
Other areas of specialty/work
Street address
Pardise department، Kmalvand region، Khorramabad، Lorestan
City
Khorramabad
Postal code
Phone
00
Fax
Email
www.a.zendedel@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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