Determining vitamin D levels in children with chronic idiopathic thrombocytopenic purpura and the effect of vitamin D supplementation on platelet increase
Design
Clinical trial study, without control group, without blinding,non-randomized- underwent on 35 patients
Settings and conduct
The technique of data collection is a census. After obtaining permission with keeping the patients' information confidential, all patients with the above characteristics at Afzalipur Hospital will be evaluated for vitamin D deficiency and the effect of vitamin D supplementation.
If their serum vitamin D level was less than 30 mg/dL, they will be given vitamin D according to the table above, and their vitamin D and platelet levels will be checked three and nine months later.
Participants/Inclusion and exclusion criteria
The criteria for entry into the study included having vitamin D level lower than 30 mg/dl , a diagnosis of chronic ITP and giving informed consent the criteria for exiting into the study included having incomplete demographic data,being reluctant to participate in the study,a history of taking vitamin D supplements for the previous 3 months at a therapeutic dose,a change in the dosage of the medications taken, and a Severe and dangerous drop in platelet levels and need for hospitalization.
Intervention groups
In patients with vitamin D levels below 30 mg/dl, vitamin D supplementation will be administered at 400 units per day for children under 1 year of age and 600 units per day for children 1-18 years of age.
Main outcome variables
Platelet counts prior to and following supplementation with vitamin D
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220817055737N1
Registration date:2022-12-23, 1401/10/02
Registration timing:retrospective
Last update:2022-12-23, 1401/10/02
Update count:0
Registration date
2022-12-23, 1401/10/02
Registrant information
Name
Abolfazl Gilani
Name of organization / entity
Tehran University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8500
Email address
a-gilani@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-19, 1400/11/30
Expected recruitment end date
2022-04-23, 1401/02/03
Actual recruitment start date
2022-02-19, 1400/11/30
Actual recruitment end date
2022-07-21, 1401/04/30
Trial completion date
2022-07-21, 1401/04/30
Scientific title
Vitamin D levels in children with chronic idiopathic thrombocytopenic purpura and the effect of vitamin D supplementation on platelet increase
Public title
Effect of vitamin D on platelet increase in chronic idiopathic thrombocytopenic purpura
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of chronic ITP
Giving informed consent
vitamin D level lower than 30 mg/dl
Exclusion criteria:
Incomplete demographic data
Being reluctant to participate in the study
History of taking vitamin D supplements for the previous 3 months at a therapeutic dose
Change in the dosage of the medications taken
Severe and dangerous drop in platelet levels and need for hospitalization
Age
To 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Actual sample size reached:
35
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
Ethics committee of Afzalipour hospital-Kerman University of Medical Sciences
Street address
Afzalipour hospital- Imam highway- Kerman
City
Kerman
Province
Kerman
Postal code
13911-76169
Approval date
2022-02-01, 1400/11/12
Ethics committee reference number
IR.KMU.AH.REC.1400.285
Health conditions studied
1
Description of health condition studied
Chronic Idiopathic Thrombocytopenic Purpura
ICD-10 code
D69.3
ICD-10 code description
Immune thrombocytopenic purpura
Primary outcomes
1
Description
Platelet counts prior to and following supplementation with vitamin D
Timepoint
Blood platelet levels were measured at the beginning of the trial and 3 & 9 months following the initiation of vitamin D supplementation.
Method of measurement
Blood platelet levels
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In patients with vitamin D levels below 30 mg/dl, vitamin D supplementation will be administered at 400 units per day for children under 1 year of age and 600 units per day for children 1-18 years of age.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Blood clinic- Afzalipour hospital
Full name of responsible person
Noushin Jahantighi
Street address
Afzalipour hospital, Imam Highway,Kerman
City
Kerman
Province
Kerman
Postal code
13911-76169
Phone
+98 34 3132 8000
Email
international@kmu.ac.ir
2
Recruitment center
Name of recruitment center
Endocrine clinic-Afzalipour hospital
Full name of responsible person
Farzaneh Yazdi
Street address
Afzalipour hospital, Imam Highway,Kerman
City
Kerman
Province
Kerman
Postal code
13911-76169
Phone
+98 34 3322 2250
Email
drfarzaneh.yazdi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
Kerman University of medical sciences Vice Chancellor-Ebn -Sina St-Tahmasb Abad-Kerman
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3857
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Arak University of Medical Sciences
Full name of responsible person
Roham Sarmadian
Position
Research Asistant
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
infectious Disease Research Center,Arak University of Mediacl Sciences,Arak
City
Arak
Province
Markazi
Postal code
3813691954
Phone
+98 86 3147 3521
Email
rsarmadian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Pouria Salajegheh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Afzalipour Hospital- Imam highway- Kerman
City
کرمان
Province
Kerman
Postal code
13911-76169
Phone
+98 34 3245 8892
Email
salajegheh.poorya@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abolfazl Gilani
Position
Research Asistant
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Tehran University of Medical Sciences,Poursina St,Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8889 6696
Fax
Email
Abol.gilani95@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
After de-identification, data on research outcomes are available for release.
When the data will become available and for how long
Access to the data is permitted for up to 2 years following the completion of the study and publication of the study and publication of the study s main article.
To whom data/document is available
The data and the outcomes of which will be published in the form of article will only be accessible to the researchers from academic institutions collaborating with Kerman University of Medical Sciences.
Under which criteria data/document could be used
The suggested study protocol must be submitted to Kerman University of Medical Sciences, and the university s scientific-technical commitee must approve its scientific validity and relevance.
From where data/document is obtainable
Mr.Poorya Salajegheh can be contacted at the email address salajegheh.poorya@gmail.com.
What processes are involved for a request to access data/document
The relevant requests will be provided to the requesting researcher as a collaborative project following assessment and approval by the relevant officials.