Recognition of effect of iron replacement therapy on reversibility of arrhythmogenic ECG parameters and as result more attention to treatment of iron deficiency for preventing of complications such as arrhythmia, syncope and sudden cardiac death.
Design
Ferritin deficient patients will be treated by elemental iron(5 mg/kg) and the ECG parameters including P wave duration,QTc and Twave peak to end distance will be evaluated before and after treatment.There is no control group.
Settings and conduct
9-18 years old persons came to health centers of Birjand city with low serum ferritin will be evaluated by history and physical examination and standard 12 lead ECG will be taken.
Participants/Inclusion and exclusion criteria
9-18 years old adolescents living in Birjand with serum ferritin below 15 mg/dl
Intervention groups
In this group,iron deficient patients will be treated by supplement iron tablets(dose:3-5 mg/kg).and ECG parameters before and after therapy will be compared.
Main outcome variables
Arrhythmogenic ECG parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190114042357N1
Registration date:2019-03-13, 1397/12/22
Registration timing:registered_while_recruiting
Last update:2019-03-13, 1397/12/22
Update count:0
Registration date
2019-03-13, 1397/12/22
Registrant information
Name
Vahid Shahriari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5000
Email address
shahriarivahiddr@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-30, 1397/11/10
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of standard Iron replacement therapy on ECG parameters in 9-18 years old adolescents
Public title
Comparison of ECG parameters before and after iron replacement therapy in iron deficient adolescents.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Parental concest
Patient cooperation for taking history, physical examination,ECG and blood sampling
Absence of inflammatory disease during three weeks according to history and physical examination.
Absence of chronic renal disease
Absence of rheumatologic,collagen vascular or other chronic disease
Absence of any cardiac disease including congenital or inflammatory.
Absence of any drug consumption in three recent weeks because of any probable effect on ECG parameters
Exclusion criteria:
Acute inflammatory disease
Hypothyroidism
Age
From 9 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Birjand university of medical sciences
Street address
Ghafari Blvd.
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
IR.BUMS.REC.1397.073
Health conditions studied
1
Description of health condition studied
Iron deficiency
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum ferritin level
Timepoint
QTc distance measurement
Method of measurement
Ferritin measurment by electrochemiluminescence method by Cobas Japan and Roche kit Germany.
Secondary outcomes
1
Description
Serum ferritin level
Timepoint
QTc distance measurment
Method of measurement
Ferritin measurment by electrochemiluminescence method by Cobas Japan and Roshe kit Germany
Intervention groups
1
Description
Patients with ferritin below 15 mg/dl and their parents will be educated for treatment of iron deficiency and importance of continuing treatment.Then will be treated by iron replacement with trade name of ferrous sulfate made by Daroopakhsh company and bach number:769,including 50 milligram of elemental Iron, 3 to 5 milligram per kilogram(max dose 150 mg) for 3 months. finally they will be visited and history and physical exam will be done.Then 12 lead standard electrocardiogram and blood sample for CBC and Ferritin will be taken similar to before treatment. Ferritin must be above 15 or the patient will be excluded of research. Then electrocardiogram markers will be conferred with before treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Birjand university of medical sciences
Full name of responsible person
Vahid Shahriari
Street address
Ghafari Blvd
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
shahriarivahiddr@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tooba Kazemi
Street address
Ghafari Blvd
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
shahriarivahiddr@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Vahid Shahriari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Birjand University of medical sciences, Ghafari Blvd
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
shahriarivahiddr@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Vahid Shahriari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Birjand University of medical sciences, Ghafari Blvd
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
shahriarivahiddr@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Vahid Shahriari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Birjand University of medical sciences, Ghafari Blvd
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
shahriarivahiddr@bums.ac.ir
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
Labolatory results
ECG records
When the data will become available and for how long
6 months after publication of results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Use in systematic reviews
From where data/document is obtainable
Via e-mail address:shahriarivahiddr@bums.ac.ir
What processes are involved for a request to access data/document
Request by e-mail and sending of results about two months later