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

NCT05470998 | Completed Phase 3

• 1 other identifier: L-Arginine 2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP)

  3 months

• change in serum level of L-Arginine

  3 months

• change in serum level of Asymmetric Dimethyl Arginine (ADMA)

  3 months

• change in serum level of Nitric Oxide

  3 months

Study Arms (2)

control group

NO INTERVENTION

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

L-Arginine group

ACTIVE COMPARATOR

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

Drug: L-Arginine

Interventions

L-Arginine DRUG

L-Arginine 1000 mg free form, rapid release capsules

L-Arginine group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
• age 5-18 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university

Tanta, Other (Non U.s.), Egypt

Location

Related Publications (1)

• Gomaa DA, El-Haggar SM, El-Shanshory MR, El-Razaky O, El-Afify DR. Clinical Study to Evaluate the Possible Efficacy and Safety of L-Arginine in Children with Sickle Cell Disease and Increased Tricuspid Regurgitant Jet Velocity: a Randomized Controlled Trial. Paediatr Drugs. 2025 Sep;27(5):605-618. doi: 10.1007/s40272-025-00701-w. Epub 2025 Jun 17.

  PMID: 40526198 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Arginine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• dalia A gomaa

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: demonstrator at clinical pharmacy department, faculty of pharmacy

Study Record Dates

• First Submitted: July 17, 2022
• First Posted: July 22, 2022
• Study Start: July 25, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 22, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)