evaluation of patients with sickle cell and sickell thalassemia after treatment with l-glutamin
Design
Randomised 15 patients were studied.
Settings and conduct
an outpatient patient will receive a L-glutamine of 10 to 30 grams per day, and the rate of pain crisis was assessed before the intervention, at the end of the fourth week and the eighth week.
Participants/Inclusion and exclusion criteria
patients with sickle cell and sickell thalassemia -renal impairment- kidney imparment-HB<5 gr -need to emergengy transfusion- pregnancy - admition more than 10 times -sensivity to l glutamin
Intervention groups
L-glutamin drug
Main outcome variables
crisis event at the end of the fourth week and the eighth week.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180603039959N1
Registration date:2020-01-10, 1398/10/20
Registration timing:retrospective
Last update:2020-01-10, 1398/10/20
Update count:0
Registration date
2020-01-10, 1398/10/20
Registrant information
Name
bijan keikhaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3375 0410
Email address
keikhaeib@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-21, 1397/03/31
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of L- glutamine in the control of crisis event in patients with sickle cell and sickell thalassemia
Public title
The efficacy of L- glutamine in sickle cell and sickell thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with sickle cell and sickell thalassemia
Exclusion criteria:
Kidney impairment
Renal impaiment
HB <5 gr
Need to emergency transfusion
Pregnancy
Admition more than 10 times
Sensivity to glutamin
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
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 ahvaz Jondyshapur University of Medical
Street address
golestan ave-baghayi hospital
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-05-11, 1397/02/21
Ethics committee reference number
IR.AJUMS.REC.1397.121
Health conditions studied
1
Description of health condition studied
sickle cell and sickell thalassemia
ICD-10 code
D57
ICD-10 code description
Sickle-cell disorders
Primary outcomes
1
Description
effect to crisis event
Timepoint
at the end of fourth and eighth week
Method of measurement
pain-admition times-crisis
Secondary outcomes
1
Description
crisis event
Timepoint
at the end of fourth and eight weeks
Method of measurement
Face Pain Scale
Intervention groups
1
Description
15 patient with sickle cell and sickell thalassemia that have slection criteria were selected.In this study, an outpatient patient will receive a L-glutamine of 10 to 30 grams per day, and rate of crisis was assessed before the intervention, at the end of the fourth week and the eighth week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghayi 2 Hospital
Full name of responsible person
Neda Farmani Anooshe
Street address
Golestan Blvd-Baghayi hospital 2
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3375 0410
Fax
Email
nedafarmanianoosheh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Bdavi
Street address
Baghayi hospital
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3375 0410
Email
nedafarmanianoosheh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Farmani Anooshe
Position
assistant
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Baghayi Hospital
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 41 3336 1658
Email
nedafarmanianoosheh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Farmani Anoosheh
Position
assistant
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Baghayi hospital 2
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 41 3336 1658
Email
nedafarmanianoosheh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Farmani Anooshe
Position
assistant
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Baghayi Hospital 2
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 41 3336 1658
Email
nedafarmanianoosheh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
there is no plan for republication
When the data will become available and for how long
there is no plan for republication
To whom data/document is available
there is no plan for republication
Under which criteria data/document could be used
there is no plan for republication
From where data/document is obtainable
there is no plan for republication
What processes are involved for a request to access data/document