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The effect of vit D supplement on ejection fraction, ferritin and hypertention in beta-thalassaemia major patients

Protocol summary

Summary
The aim of this study was the effect of vitamin D supplementation on cardiac output, pulmonary artery pressure, serum ferritin and blood pressure in patients with thalassemia major is. This study is a clinical trial 33 patients with thalassemia referred to thalassemia ward has Exclusion criteria: other concurrent diseases, including heart disease; Diabetes; Hepatitis; Hypo-parathyroid; Less than 35% of cardiac output method selected by convenience sampling thalassemia major, iron overload is that they have no heart or sediment are mild, measured levels of vitamin D, ferritin and blood pressure measurement is performed. In case of low vit D of 74 nmol l or 29 ng per ml, is studied. The patients underwent echocardiography and cardiac output are measured and also vitamin D3 during the twelve week treatment at a dose of 50,000 IU per week begins. After 3 months, the level of vitamin D, ferritin and blood pressure were measured and in case of normal vitamin D levels, the second echo is done. Low vitamin D in vitamin D treatment will be repeated once again. Patients with improved cardiac output, blood pressure, pulmonary blood pressure ferritin levels are considered to be responding to treatment

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022110222N5
Registration date: 2016-03-04, 1394/12/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-03-04, 1394/12/14
Registrant information
Name
Zahra Keivani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
keivani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vit D supplement on ejection fraction, ferritin and hypertention in beta-thalassaemia major patients
Public title
The effect of vit D supplement on ejection fraction, ferritin and hypertention in beta-thalassaemia major patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients with thalassemia major with vitamin D levels less than 74 nmol . L or 29 ng . ml Exclusion criteria:other concurrent diseases, including heart disease; Diabetes; Hepatitis; Hypo-parathyroid; Cardiac output less than 35%
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 33
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 Shahrekord University of Medical Sciences
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Approval date
2015-08-30, 1394/06/08
Ethics committee reference number
IR.SKUMS.REC.1394.63

Health conditions studied

1

Description of health condition studied
cooley anemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia

Primary outcomes

1

Description
cardiac out put
Timepoint
Baseline andThree months later
Method of measurement
echocardiography

2

Description
blood pressure
Timepoint
Baseline andThree months later
Method of measurement
Barometer

3

Description
pulmonary hypertention
Timepoint
Baseline and quarterly
Method of measurement
echocardiography

4

Description
ferittin level
Timepoint
Baseline andThree months later
Method of measurement
blood sample

Secondary outcomes

empty

Intervention groups

1

Description
Patients with thalassemia major with iron overload or precipitate heart they do have mild, measured levels of vitamin D, ferritin and blood pressure measurement is performed. Vit D level of 74 nmol being in lower case l or 29 ng per mm Lytrbashnd, is studied. The patients underwent echocardiography and cardiac output are measured and also vitamin D3 during the twelve week treatment at a dose of 50,000 IU per week begins. After 3 months, the level of vitamin D, ferritin and blood pressure were measured and in case of normal vitamin D levels, the second echo is done. Low vitamin D in vitamin D treatment will be repeated once again
Category
Early detection

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Kiavash Fekri
Street address
Shahrekord, Shahrekord University Of Medical Sciences
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University of Medical Science
Full name of responsible person
Dr.Kamal Solati
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
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 of Shahrekord University of Medical Science
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
Shahrekord University of Medical Sciences
Full name of responsible person
Kiavash Fekri
Position
Professor of Pediatrics, Assistant Professor
Other areas of specialty/work
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38332220016
Fax
Email
k.fekri@skums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical
Full name of responsible person
Kiavash Fekri
Position
Professor of Pediatrics, Assistant Professor
Other areas of specialty/work
Street address
Shahrekord , Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38332220016
Fax
Email
k.fekri@skums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Kiavash Fekri
Position
Professor of Pediatrics, Assistant Professor
Other areas of specialty/work
Street address
Shahrekord, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38332220016
Fax
Email
k.fekri@skums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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