L-Arginine and Sickle Cell Disease

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

One of the main problems in sickle cell disease is the decreased bioavailability of nitric oxide and arginine. This study was designed to assess if treating sickle cell disease patients with L-arginine would improve pulmonary arterial pressure and other aspects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Ajinomoto Interamericana Indústria e Comércio Ltda. (donation of L-arginine); Associação de Amigos da Hematologia (HEMOAMIGOS); Fundo de Incentivo à Pesquisa do Hospital de Clinicas de Porto Alegre (FIPE)

Criteria

Inclusion Criteria:

• Diagnosis of sickle cell disease confirmed through hemoglobin electrophoresis

• Genotypes SS, SC and Sβ thalassemia

• Age > 1 year

Exclusion Criteria:

• Liver dysfunction (alanine aminotransferase ALT > 3 times the normal levels

• Renal dysfunction (creatinine > twice the normal levels)

• Increase in methemoglobin levels (> 5 times the normal levels)

• History of recent stroke (< 1 month) and priapism

• Pregnancy

• Allergy to L-arginine

• Use of sildenafil, calcium channel blockers, nitroglycerin or other nitrates