The Efficacy of Oral L-Arginine Therapy for The Treatment of Vaso-Occlusive Pain Episodes in Children with Sickle Cell Disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202507722471802

Enrollment

Registered

2025-07-09

Start date

2022-08-10

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haematological Disorders Paediatrics

Interventions

L Arginine

Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All Children with SCD who present with VOE and their age ranged from 5-18 years were included

Exclusion criteria

Exclusion criteria: 1) Hepatic dysfunction (Serum Alanine Aminotransferase (ALT) > 3 folds upper value, 2) Renal dysfunction (Creatinine level greater than or equal to 1.2 mg/dl), 3) Active infection (e.g., influenza, COVID-19), 4) Prior participation in the study, 5) Allergy to L-arginine or had received any new drug had been excluded from the current study.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of L-arginine as an adjuvant therapy in SCD children with VOE on pain using the Numerical Pain Rating Scale	—

Secondary

Measure	Time frame
To evaluate total analgesic use, time to crisis resolution and length of hospital stay between the two studied groups, to compare between the two studied groups in the level of Arginine, ADMA, Arginine/ADMA ratio and Tricuspid Regurgitant Jet Velocity to detect the effect of arginine supplementation, Additionally, Arginine, ADMA, Arginine/ADMA ratio and TRJV were assessed during the clinically asymptomatic state (The clinically asymptomatic state is defined as being free of pain at least 4 weeks after the last acute SCD related complication) and compared with their values at baseline during painful crisis for all 40 patients to detect the effect of painful crisis.	—

Measure

Time frame

To evaluate total analgesic use, time to crisis resolution and length of hospital stay between the two studied groups, to compare between the two studied groups in the level of Arginine, ADMA, Arginine/ADMA ratio and Tricuspid Regurgitant Jet Velocity to detect the effect of arginine supplementation, Additionally, Arginine, ADMA, Arginine/ADMA ratio and TRJV were assessed during the clinically asymptomatic state (The clinically asymptomatic state is defined as being free of pain at least 4 weeks after the last acute SCD related complication) and compared with their values at baseline during painful crisis for all 40 patients to detect the effect of painful crisis.

—

Countries

Egypt

Contacts

Public ContactMohamed Ramadan ElShanshory

Professor of pefiatrics

elshanshory@gmail.com01008160845

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026