Protocol summary

Summary
The aim of this study (a clinical trial) is evaluating the effect of vitamin D deficiency treatment on relieving the clinical Symptoms and spirometric indices in patients suffering from COPD. Sixty patients who are suffering from COPD and vitamin D deficiency (less than 30ng/dl), are 30-80 years old enter the research based on inclusion Criteria. These patients are selected from lung clinic in Valiasr hospital. Then Patients are divided to 2 group and each group have 30 patients through simple random sampling method. In First group (drug group), one 50000 IU purl of vitamin D, every week for 3 continuous months and one calcium-D tablet daily will be prescribed in addition to standard COPD treatment. Second group (placebo group) will receive placebo, every week for 3 months in addition to standard COPD treatment. At the beginning and after 3 months, the spirometry process and measurement of 25 OH vitamin D, Calcium (ca), Phosphorus (p), Albumin and Parathyroid Hormone (PTH) will be performed for all patients. Every month Patients will be controlled from the perspective of drug consumption and correct using of it and they will be excluded if the exclusion criteria met (renal disease, liver disease, parathyroid disease, malnutrition, malabsorption). In this study, increase of Forced expiratory volume during the first second (FEV1), Forced expiratory volume during the first second / Forced Vital Capacity (FEV1/FVC) and 25 (OH) Vit D in first group compared to second group as a primary consequence and reduction of Dyspnea severity based on MRC criteria in first group compared to second group, will be discussed as secondary outcome.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017042919554N12
Registration date: 2017-10-27, 1396/08/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-27, 1396/08/05
Registrant information
Name
Maryam Jameshorani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00989126416972 و 00982433770805
Email address
dr.shirinjameshorani@zumc.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zanjan University of Medical Sciences.
Expected recruitment start date
2016-07-20, 1395/04/30
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of vitamin D and placebo on clinical and spirometric indices in patients with chronic obstructive pulmonary disease (COPD).
Public title
The effect of vitamin D deficiency treatment on dyspnea severity in patients with COPD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Outpatients suffering from COPD who haven’t had COPD exacerbation in last 2 weeks; serum vitamin D level less than 30 ng / dl; written consent for participating in the study. Exclusion Criteria: liver problems (LFT equal to or more than 2 times more than normal); renal failure (GFR<60); Granulomatous diseases (including tuberculosis, sarcoidosis); malnutrition; malabsorption (including IBD and Celiac); any types of cancer; parathyroid disease.
Age
From 30 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
the patients categorized non-randomly into groups treated with vitamin D (with the assignment of zero and even numbers) and placebo (by assigning individual numbers).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Karmandan street, Zanjan
City
Zanjan
Postal code
4415777978
Approval date
2016-11-23, 1395/09/03
Ethics committee reference number
ZUMS.REC.1395.202

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J43, J44.8
ICD-10 code description
Emphysema -Other specified chronic obstructive pulmonary disease-Chronic obstructive pulmonary disease, unspecified- -

Primary outcomes

1

Description
Forced expiratory volume (FEV1)
Timepoint
Before the intervention and three months after the end of intervention
Method of measurement
spirometery

2

Description
Forced expiratory volume 1/ Forced vital capacity(FEV1/FVC)
Timepoint
Before the intervention and three months after the end of intervention
Method of measurement
Spirometry

Secondary outcomes

1

Description
severity of Dyspnea
Timepoint
Before the intervention and three months after the end of intervention
Method of measurement
MRC Dyspnoea Scale

2

Description
Weight
Timepoint
Before the intervention and three months after the end of intervention
Method of measurement
Scale

Intervention groups

1

Description
Intervention group: 50000 IU Pearl vitamin D every week and 500mg calcium-D tablet daily (for three month)
Category
Treatment - Drugs

2

Description
Control group: Perl placebo every week and calcium-D 500 mg tablets daily (for three months)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Respirarory clinic, Vali-Asr Hospital
Full name of responsible person
Maryam Jameshorani
Street address
Valiasr hospital, Valiasr Sq, Zanjan
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Zanjan University of Medical Sciences.
Full name of responsible person
Alireza Shoghli.
Street address
Zanjan University of Medical Sciences, Karmandan street, Zanjan
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Maryam Jameshorani
Position
Internal medicine specialist, Assistant Professor of University
Other areas of specialty/work
Street address
Valiasr hospital, Valiasr Sq., Zanjan
City
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0723
Fax
+98 24 3377 0723
Email
ZMDRC@zums.ac.ir
Web page address
www.zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Maryam Jameshorani
Position
Internal medicine specialist
Other areas of specialty/work
Street address
Valiasr hospital, Valiasr Sq.,Zanjan
City
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0723
Fax
+98 24 3377 0815
Email
ZMDRC@zums.ac.ir
Web page address
www.zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Maryam Jameshorani
Position
Internal medicine specialist, Assistant Professor of University
Other areas of specialty/work
Street address
Valiasr hospital, Valiasr Sq., Zanjan
City
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0723
Fax
+98 24 3377 0723
Email
ZMDRC@zums.ac.ir
Web page address
www.zums.ac.ir

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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