NCT01142219

L-Arginine and Sickle Cell Disease

A Randomized, Controlled, Double-blind Clinical Trial of L-arginine as Adjuvant Therapy for Sickle Cell Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

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 either L-arginine or placebo orally. Adverse events were monitored by a safety committee. The variables were assessed while patients were in remission, as part of their routine care: weight, blood pressure, full blood cell count, creatinine and dosage of methemoglobin at baseline and at each follow-up visit. Peripheral oxygen saturation (SpO2), fetal hemoglobin, lactate dehydrogenase and tricuspid regurgitant jet velocity were measured through transthoracic Doppler echocardiogram before and after treatment.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	L-arginine	L-arginine was administered orally at a dose of 0.1g/kg/day during 6 months.
DRUG	Placebo	Mannitol was administered orally at a dose of 01 g/kg/day for six months.

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-01-01
• Completion: 2009-10-01
• First posted: 2010-06-11
• Last updated: 2010-06-11

Locations

1 site across 1 country: Brazil