Sickle Cell Disease
Conditions
Brief summary
This study aims to investigate the possible efficacy and safety of L-Arginine in children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
Interventions
DRUGL-Arginine
L-Arginine 1000 mg free form, rapid release capsules
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity * age 5-18 years
Exclusion criteria
* Another chronic hemolytic anemia. * Patients with documented causes of pulmonary hypertension other than SCD. * Allergy to L-arginine. * Patients with Asthma. * Hepatic dysfunction: serum Alanine Aminotransferase (ALT) \> 3X upper value. * Renal dysfunction: Creatinine level greater than or equal to 1.2 mg/dl.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography | 3 months | patients will undergo Color Doppler Echocardiography to assess tricuspid regurgitant jet velocity (TRJV) at baseline and after 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP) | 3 months | Blood samples will be collected at baseline and after 3 months |
| change in serum level of L-Arginine | 3 months | Blood samples will be collected at baseline and after 3 months |
| change in serum level of Asymmetric Dimethyl Arginine (ADMA) | 3 months | Blood samples will be collected at baseline and after 3 months |
| change in serum level of Nitric Oxide | 3 months | Blood samples will be collected at baseline and after 3 months |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORdalia A gomaa
Tanta University
Outcome results
None listed