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L-Arginine and Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT01142219
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : June 11, 2010
Sponsor:
Collaborators:
Fundo de Incentivo à Pesquisa do Hospital de Clinicas de Porto Alegre (FIPE)
Associação de Amigos da Hematologia (HEMOAMIGOS)
Ajinomoto Interamericana Indústria e Comércio Ltda. (donation of L-arginine)
Information provided by:
Hospital de Clinicas de Porto Alegre

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-arginine would improve pulmonary arterial pressure and other aspects.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: L-arginine Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double-blind Clinical Trial of L-arginine as Adjuvant Therapy for Sickle Cell Disease
Study Start Date : September 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : October 2009


Arm Intervention/treatment
Experimental: L-arginine
0.1g/kg/day for 6 months
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.




Primary Outcome Measures :
  1. Tricuspid regurgitant jet velocity >2.5 m/s [ Time Frame: 6 months ]
    Tricuspid regurgitant jet velocity was used to assess pulmonary arterial hypertension before and after treatment with L-arginine.


Secondary Outcome Measures :
  1. Lactate dehydrogenase levels [ Time Frame: 6 months ]
    The effect of L-argigine administration on hemolysis was assessed through the variation of serum levels of lactate dehydrogenase.



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142219


Locations
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Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-001
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Fundo de Incentivo à Pesquisa do Hospital de Clinicas de Porto Alegre (FIPE)
Associação de Amigos da Hematologia (HEMOAMIGOS)
Ajinomoto Interamericana Indústria e Comércio Ltda. (donation of L-arginine)

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Responsible Party: Christina Matzenbacher Bittar, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01142219     History of Changes
Other Study ID Numbers: 04-487 cep@hcpa.ufrgs.br
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: June 2010
Keywords provided by Hospital de Clinicas de Porto Alegre:
sickle cell disease
L-arginine
hemolysis
nitric oxide
pulmonary arterial hypertension
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn