Status:
COMPLETED
L-Arginine and Sickle Cell Disease
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Fundo de Incentivo à Pesquisa do Hospital de Clinicas de Porto Alegre (FIPE)
Associação de Amigos da Hematologia (HEMOAMIGOS)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
1+ years
Phase:
PHASE3
Brief 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-arginin...
Detailed Description
This is a phase III, randomized, double-blind, placebo-controlled clinical trial with sickle cell disease patients older than 1 year of age. The patients were randomly assigned to take 0.1 g/kg/day of...
Eligibility Criteria
Inclusion
- Diagnosis of sickle cell disease confirmed through hemoglobin electrophoresis
- Genotypes SS, SC and Sβ thalassemia
- Age \> 1 year
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01142219
Start Date
September 1 2006
End Date
October 1 2009
Last Update
June 11 2010
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-001