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

Tanta University

Status and phase: Completed; Phase 3

Conditions: Sickle Cell Disease

Treatments: Drug: L-Arginine

Study type: Interventional

Funder types: Other

Identifiers

NCT05470998

L-Arginine 2021

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

control group

No Intervention group

Description:

this group will include 25 patients who will receive their standard therapy for 3 months

L-Arginine group

Active Comparator group

Description:

this group will include 25 patients who will receive L-Arginine 0.1-0.2 g/kg/day and their standard therapy for 3 months

Treatment:

Drug: L-Arginine