This is a double-blind, placebo-controlled clinical trial aimed to investigate the effect of oral vitamin D compared to placebo on symptoms resolution and reduction in severity and disease attacks in patients with bronchiectasis, in 28 patients with bronchiectasis referring pulmonology clinic of Ali Ebne Abi Taleb hospital in Zahedan. Inclusion criteria are age of more than 21 years and having bronchiectasis and vitamin D deficiency and exclusion criteria are having cardiac or renal diseases, diabetes, other pulmonary diseases and uncontrolled hypertension. After inclusion in the study, the patients will be randomly divided into two equal groups, vitamin D receivers and placebo group. Vitamin D receivers will receive 50000 I/U of this drug once a week for 2 months and the placebo group will also receive 300 mg of starch once a day for 2 months. Patients in both groups will be followed for 2 months and at the end of the second month, the number and severity of the attacks will be compared together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022532771N1
Registration date:2017-03-08, 1395/12/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-08, 1395/12/18
Registrant information
Name
Mohammad Bagher Maleki
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
m.maleki@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of oral vitamin D compared to placebo in the treatment of brochiectasis
Public title
The effect of vitamin D in bronchiectasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of more than 21 years; having bronchiectasis; having vitamin D deficiency.
Exclusion criteria: having cardiac or renal diseases; diabetes; other pulmonary diseases; uncontrolled hypertension.
Age
From 21 years old to 139 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
28
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 Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Postal code
Approval date
2017-01-26, 1395/11/07
Ethics committee reference number
IR.ZAUMS.REC.1395. 255
Health conditions studied
1
Description of health condition studied
Bronchiectasis
ICD-10 code
J47
ICD-10 code description
Bronchiectasis
Primary outcomes
1
Description
Number of attacks
Timepoint
At the end of second month
Method of measurement
By asking the patient
Secondary outcomes
empty
Intervention groups
1
Description
Vitamin D group: 50000 I/U oral vtamin D once a week for 2 months
Category
Treatment - Drugs
2
Description
Placebo group: 300 mg of starch once a day for 2 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital
Full name of responsible person
Mohammad Bagher Maleki
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Hoshang Rafighdoost
Street address
Vice chancellor for research, Zahedan University of Medical Sciences campus, Jannat Blv, Zahedan
City
Zahedan
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, Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mohammad Bagher Maleki
Position
Internal medicine resident
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan