L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity

Sickle Cell Disease Clinical Trial

Official title:

Clinical Study to Evaluate the Possible Efficacy and Safety of L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05470998
• Other study ID #: L-Arginine 2021
• Status: Recruiting
• Phase: Phase 3
• Start date: November 25, 2021
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: dalia A gomaa
• Phone: 01063410525
• Email: dalia_gomaa[@]pharm.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• L-Arginine
L-Arginine 1000 mg free form, rapid release capsules

Locations

Country	Name	City	State
Egypt	Tanta university	Tanta	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography	patients will undergo Color Doppler Echocardiography to assess tricuspid regurgitant jet velocity (TRJV) at baseline and after 3 months	3 months
Secondary	change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP)	Blood samples will be collected at baseline and after 3 months	3 months
Secondary	change in serum level of L-Arginine	Blood samples will be collected at baseline and after 3 months	3 months
Secondary	change in serum level of Asymmetric Dimethyl Arginine (ADMA)	Blood samples will be collected at baseline and after 3 months	3 months
Secondary	change in serum level of Nitric Oxide	Blood samples will be collected at baseline and after 3 months	3 months