Studying of Vitamin D Injection Effectiveness on Asthmatic Patients Improvement and Treatment
Design
A prospective open pilot study with 20 asthmatic patients in a non-blind and Single group, also non-randomised and Based on a before and after study design
Settings and conduct
Moderate to severe asthmatic patients in Bu Ali Hospital who are diagnosed by spirometry test and St. George's respiratory questionnaire (SGRQ), considering inclusion and exclusion criteria, take blood test. Vitamin D deficient patients rolls in the study and recieve two vitamin D 300,000 IU IM injection with a one month gap between. two months after the start of the study, patients take spirometry test and Fill in SGRQ and Take another blood test to evaluate 25(OH)D3 baseline again. At the end, the results will be compared with those results collected in the start of the study to observe the improvement procedure.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Moderate to Severe Asthma, ages between 18 to 75 also They must be under treatment, Plus Vitamin D deficient.
Exclusion criteria: Patients with infectious lung disease, pregnant and breastfeeding women, patients with parathyroid problems and Patients with severe kidney and liver disease
Intervention groups
Intervention group: According to their blood test result, These patients are Vitamin D deficienct and Should receive two Vitamin D ampoule 300,000 international units(IU) Intramuscularly(IM) with a one month gap between.
Control group: There is no control group in this study; hence, at the end the results will be compared with those results collected in the start of the study to observe the improvement procedure.
Main outcome variables
25(OH)D3 Baseline؛ Forced Expiratory Volume In First Second؛ Forced Vital Capacity؛ Proportion of a Person's Vital Capacity that He Is Able to Expire in The First Second of Forced Expiration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160813029327N14
Registration date:2018-07-17, 1397/04/26
Registration timing:registered_while_recruiting
Last update:2018-07-17, 1397/04/26
Update count:0
Registration date
2018-07-17, 1397/04/26
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-17, 1396/07/25
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Vitamin D Injection Dose Adjustment on Vitamin D Deficient Asthmatic Patients Improvement and Treatment
Public title
Assessment of Vitamin D Effectiveness on Asthma Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Moderate to Severe Asthma
Under Treatment Asthmatic Patients
Vitamin D Deficient Patients
Exclusion criteria:
Patients with Infectious Lung Disease
Pregnant and Breastfeeding Women
Patients with Parathyroid Problems
Severe Kidney Disease
Severe Liver Disease
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
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
Ethics Committee of Teharan Islamic Azad University of Pharmaceutical Scienses
Street address
No 99, Yakhchal Street, Gholhak Area, Shariati Ave
City
Tehran
Province
Tehran
Postal code
6466_19395
Approval date
2017-02-01, 1395/11/13
Ethics committee reference number
IR.IAU.PS.REC.1395.70
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Disorder of The Airways
Primary outcomes
1
Description
25(OH)D3 Baseline
Timepoint
Assessment of 25(OH)D3 Baseline before Starting The Intervention and Again 2 Months After The First Injection of Vitamin D Ampoule
Method of measurement
Blood Test
2
Description
Forced Expiratory Volume In First Second
Timepoint
Assessment of Forced Expiratory Volume In First Second, before Starting The Intervention and Again 2 Months After The First Injection of Vitamin D Ampoule
Method of measurement
Spirometry Device
3
Description
Forced Vital Capacity
Timepoint
Assessment of Forced Vital Capacity, before Starting The Intervention and Again 2 Months After The First Injection of Vitamin D Ampoule
Method of measurement
Spirometry Device
4
Description
Proportion of a Person's Vital Capacity that He Is Able to Expire in The First Second of Forced Expiration
Timepoint
Assessment of Proportion of a Person's Vital Capacity that He Is Able to Expire in The First Second of Forced Expiration, before Starting The Intervention and Again 2 Months After The First Injection of Vitamin D Ampoule
Method of measurement
Spirometry Device
Secondary outcomes
1
Description
Quality of Life
Timepoint
Assessment of Quality of Life of The Patient before Starting The Intervention and Again 2 Months After The First Injection of Vitamin D Ampoule
Method of measurement
St. George's Respiratory Questionnaire
Intervention groups
1
Description
Intervention group: It includes asthmatic patients with 25(OH)D3 baseline under 20 ng/ml (Vitamin D deficiency). So They need to take blood test in order to evaluate 25(OH)D3 baseline first. After they are diagnosed with Vitamin D deficiency, Vitamin D Ampoule 300,000 IU is injected to them intramuscularly(IM) once in the first month of the study and the second Vitamin D Ampoule injection, one month after the first injection, is taken again IM. Furthermore, their respiratory condition should be checked by the spirometry test and St. George's respiratory questionnaire once in the first step of the study and Then again, two months later. Moreover, another blood test two month after the first injection should be taken to see if their 25(OH)D3 baseline is corrected. Finally the results of Blood test, Spirometry test and St. George's respiratory questionnaire which were collected in the first step of the study will be compared with the ones collected after two months of follow up to see if this type of intervention is beneficial for the patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Hospital
Full name of responsible person
Hamid Reza Moezi
Street address
Damavand Avenue, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
17117
Phone
+98 21 3334 8035
Email
hmoezzi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arian Dokht Eini Sadr
Street address
No. 99, Islamic Azad University of Pharmaceutical Science, Yakhchal St, Gholhak Area, Shariati Ave
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 2264 0051
Email
arianeinisadr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Arian Dokht Eini Sadr
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Mehdi Rajabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 99, Islamic Azad University of Pharmaceutical Science, Yakhchal St, Gholhak Area, Shariati Ave
City
Tehran
Province
Tehran
Postal code
6466_19395
Phone
+98 21 2264 0051
Email
mehdirj@aol.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Reza Moezi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Lung Disease
Street address
Damavand Avenue, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
17117
Phone
+98 21 3334 8035
Email
hmoezzi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arian Dokht Eini Sadr
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No. 99, Islamic Azad University of Parmaceutical Science, Yakhchal St, Gholhak Area, Shariati Ave
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 2264 0051
Email
arianeinisadr@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available