L-Arginine and Sickle Cell Disease

June 10, 2010 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-001
        • Hospital de Clinicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Estimate)

June 11, 2010

Last Update Submitted That Met QC Criteria

June 10, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-487 cep@hcpa.ufrgs.br

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sickle Cell Disease

Clinical Trials on L-arginine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe