L-Arginine and Sickle Cell Disease

H

Hospital de Clinicas de Porto Alegre

Status and phase

Completed
Phase 3

Conditions

Sickle Cell Disease

Treatments

Drug: L-arginine
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01142219
04-487 cep@hcpa.ufrgs.br

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 1 patient group

L-arginine
Experimental group
Description:
0.1g/kg/day for 6 months
Treatment:
Drug: Placebo
Drug: L-arginine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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