The effect of oral L-arginine supplementation on improvement of cardiovascular function and pulmonary artery pressure in patients with major and Intermedia beta-thalassemia
The effect of L-arginine supplementation on improving pulmonary pressure in patients with beta thalassemia
Design
A clinical trial study with a control group with a parallel and double-blind randomized group on 88 patients
Settings and conduct
Patients with beta thalassemia major and transfusion-dependent intermediate media over 15 years of age Referred to Ali Asghar Hospital for treatment Based on the criteria measured in echocardiography and diagnosis of a cardiologist Patients with increased pulmonary artery pressure (PHTN) (pulmonary artery pressure above 25 mm Hg at rest) Identified and studied. 44 of these patients received oral L-arginine supplements in oral vials Another 44 people took placebo in the form of an oral vial similar to the main drug It is given over a period of two months And after 8 weeks to evaluate the effect of this supplement in both groups Echocardiography and cardiac re-examination are performed.Selection of patients are randomization and double-blind (patient and distributor and analyzer ...)
Participants/Inclusion and exclusion criteria
Patients with pulmonary artery pressure above 25 mm Hg at rest have been identified are included in the study. Patients with severe heart disease who need specialized measures and treatments Or have already been treated with heart medication, Patients with severe liver and kidney disease, diabetics, pregnant and lactating women And people who have been taking protein supplements for the last 6 months will be excluded from the study
Intervention groups
In 44 of these patients, oral L-arginine supplement in the form of oral vials and Another 44 people are given placebo in the form of an oral vial similar to the original medicine
Main outcome variables
Age. Gender. Ferritin level. Hemoglobin . History of splenectomy. Chelator drug used. Frequent transfusions .Ejection Fraction and PHTN before and after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210220050430N1
Registration date:2021-05-07, 1400/02/17
Registration timing:prospective
Last update:2021-05-07, 1400/02/17
Update count:0
Registration date
2021-05-07, 1400/02/17
Registrant information
Name
maryam shamspour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2262 2847
Email address
maryam.shams2744@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral L-arginine supplementation on improvement of cardiovascular function and pulmonary artery pressure in patients with major and Intermedia beta-thalassemia
Public title
The effect of oral L-arginine supplementation on improvement of cardiovascular function and pulmonary artery pressure in patients with major and Intermedia beta-thalassemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Beta thalassemia major
Above 15 years
Thalassemia intermedia
Exclusion criteria:
Pregnancy
Diadetes
Sever kidney disease
Sever liver disease
Sever cardiac disease
History of taking this supplement
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling is simple in that the names of all patients of thalassemia over 15 years is written and 88 people, which is equivalent to the sample size, will be selected by lot and Permuted- Block randomization are divided into two groups 8 blocks consisting of 4 participants in the intervention group and 4 participants in the control group. Block randomization is one of the limited randomization methods and is a Double-blind study
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the drug and placebo were labeled by the manufacturer Group A and Group B. Which are quite similar in appearance and the person participating in the study and the person distributing the medicine does not know about this labeling
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Medical scool of Iran university of medical sciences
Street address
Medical school of Iran university , Next Milad tower . Hemat highwey . Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-11-21, 1399/09/01
Ethics committee reference number
IR.IUMS.FMD.REC.1399.641
Health conditions studied
1
Description of health condition studied
Betha thalasemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Pulmonary hypertension
Timepoint
2 month
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Give oral vial L-arginine supplement made by iranian bio fermentation company with dose 0.1 gr /kg divided 2 or 3 time for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: give oral vial placebo made by iranian bio fermentation company similer to the main drug contain oral glucose for 8 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali asghar Pediatric of Hospital
Full name of responsible person
Shahla Ansai damavandi
Street address
No .193 . Aliasghar- Pediatric of Hospital. Hematology clinic . .Dastgardi street, North Modares highwey . Tehran . Iran
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2041
Email
shahladamavandi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Abas Motevalian
Street address
No 424. 3floor . Research office. Medical school of Iran university .Hemat highwey . Tehran .Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1021
Email
iumspr@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?