effect of vitamin D supplementation on asthma course
Design
single arm study without randomization and blinding
Settings and conduct
Besat Hospital Patients Considering inclusion and exclusion Criteria who were willing to participate in the project. After obtaining consent from the patient and the parents, they examined for serum vitamin levels D by blood sampling.
Samples are collected and then extracted from the plasma by a vitamin D assay kit under the supervision of a laboratory expert or pathologist. People with vitamin D deficiency are enrolled in the study.
After the completion of the treatment period, the patient is re-tested and paraclinical evaluated for severity of asthma.
According to the Approved guideline by the Northamptonshire Prescribing Advisory Group, the treatment of vitamin D deficiency:
patients with deficiency of vitamin D (<25nmol/l):
At the primary care level the Fultium-D3 800IU capsule, 4 capsules daily for 84 days (12 weeks)
At the second care level, D3-50 50,000 IU, one tablet daily for 6 days or Cholecalciferol 300,000 units can be injected intramuscular monthly for 3 months
For patients with insufficiency of vitamin D (25-50 nmol/l), according to the patient's calcium level and according to the physician opinion.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Patients with asthma
exclusion criteria:
1-Unwilling to participate in the study
2. Identify any disorder or chronic illness (including kidney and liver disease)
3. Malignancy
4. Muscular musculoskeletal disorders including rickets and osteomalacia
5. Vitamin D intake as a medicine and nutritional supplement
6.Use of drugs that may have an effect on vitamin D metabolism, including anticonvulsants
7. Normal level of vitamin D after measurement
Intervention groups
Patients aged 6 to 18 years with asthma
Main outcome variables
FEV1
exacerbation
The severity of asthma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171222037986N1
Registration date:2018-08-01, 1397/05/10
Registration timing:retrospective
Last update:2018-08-01, 1397/05/10
Update count:0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
Rasol Nasiri Kalmarzi
Name of organization / entity
Kurdistan university of medical scions
Country
Iran (Islamic Republic of)
Phone
+98 87 3323 0524
Email address
rnasiri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-13, 1396/12/22
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
2015-04-01, 1394/01/12
Actual recruitment end date
2017-04-20, 1396/01/31
Trial completion date
empty
Scientific title
Evaluation of the vitamin D supplementation effect on the course of asthma
Public title
The role of vitamin D in the course of asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with asthma based on history and physical examination or PFT findings.
Willing to participate in the study
No previous disease are known.
Vitamin D Deficiency
Exclusion criteria:
The person's unwillingness to continue to collaborate on the study
Recognition of any disorder or chronic illness during the study (including kidney or liver disease)
Malignancy
Musculoskeletal disorders including rickets and osteomalacia
Taking vitamin D 'as a medicine or a nutritional supplement
Use of drugs that may have an effect on vitamin D metabolism, including anticonvulsants
The normal level of vitamin D after measuring its serum levels
Age
From 6 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Actual sample size reached:
52
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
Kurdistan University of Medical Science
Street address
Kurdistan University of Medical Sciences Vice Chancellor in Research Affair, Pasdaran Ave., Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
13446ـ66177
Approval date
2018-03-13, 1396/12/22
Ethics committee reference number
IR.MUK.REC.1396/366
Health conditions studied
1
Description of health condition studied
asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Asthma severity
Timepoint
12 weeks
Method of measurement
based on examinations, PFT and History tacking
2
Description
exacerbation
Timepoint
Upon arrival to 12 weeks later
Method of measurement
Coughing attacks, shortness of breath and wheezing caused by exacerbation of asthma
3
Description
FEV1
Timepoint
Coming in and 12 weeks later
Method of measurement
Spirograph chart
Secondary outcomes
empty
Intervention groups
1
Description
According to the Approved guideline by the Northamptonshire Prescribing Advisory Group, the treatment of vitamin D deficiency: patients with deficiency of vitamin D (<25nmol/l): At the primary care level the Fultium-D3 800IU capsule, 4 capsules daily for 84 days (12 weeks) At the second care level, D3-50 50,000 IU, one tablet daily for 6 days or Cholecalciferol 300,000 units can be injected intramuscular monthly for 3 months For patients with insufficiency of vitamin D (25-50 nmol/l), according to the patient's calcium level and according to the physician opinion. the clinic of Besat Hospital of Sanandaj
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Rasoul Nasiri Kalmarzi
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3323 0524
Email
rasool_nsr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Rasoul Nasiri Kalmarzi
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3366 4645
Email
rasool_nsr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Saywan Ahmadi
Position
Medical Student, Member of the Student Research Committee
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3366 4645
Email
saywanahmadi1992@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Rasoul Nasiri Kalmarzi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3323 0524
Email
rasool_nsr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Khalafi
Position
Research Assistant (Researcher Deuty Soldier)
Latest degree
Medical doctor
Other areas of specialty/work
Public Health
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3366 4645
Email
khalafi.behzad70@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is from the proposal, raw data and project reports
When the data will become available and for how long
Data is available from the legal system six months after publication for two years
To whom data/document is available
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences.
Under which criteria data/document could be used
For legal issues and the need to use data in future studies
From where data/document is obtainable
By submitting a request to the Delegation for Research and Technology and approving the Ethics Committee - Rasoul Nasiri Kalmarzi MD
What processes are involved for a request to access data/document
After submitting a request to the Kurdistan Research and Technology Dept. of Science and Technology, a call for submission is given.