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L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05470998
Recruitment Status : Recruiting
First Posted : July 22, 2022
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Dalia Abdelhamid Gomaa, Tanta University

Study Description
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Brief Summary:
This study aims to investigate the possible efficacy and safety of L-Arginine in children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Possible Efficacy and Safety of L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity
Actual Study Start Date : November 25, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: control group
this group will include 25 patients who will receive their standard therapy for 3 months
Active Comparator: L-Arginine group
this group will include 25 patients who will receive L-Arginine 0.1-0.2 g/kg/day and their standard therapy for 3 months
 Drug: L-Arginine
L-Arginine 1000 mg free form, rapid release capsules


Outcome Measures
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Primary Outcome Measures :
  1. change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography [ Time Frame: 3 months ]
    patients will undergo Color Doppler Echocardiography to assess tricuspid regurgitant jet velocity (TRJV) at baseline and after 3 months


Secondary Outcome Measures :
  1. change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP) [ Time Frame: 3 months ]
    Blood samples will be collected at baseline and after 3 months

  2. change in serum level of L-Arginine [ Time Frame: 3 months ]
    Blood samples will be collected at baseline and after 3 months

  3. change in serum level of Asymmetric Dimethyl Arginine (ADMA) [ Time Frame: 3 months ]
    Blood samples will be collected at baseline and after 3 months

  4. change in serum level of Nitric Oxide [ Time Frame: 3 months ]
    Blood samples will be collected at baseline and after 3 months


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
  • age 5-18 years

Exclusion Criteria:

  • Another chronic hemolytic anemia.
  • Patients with documented causes of pulmonary hypertension other than SCD.
  • Allergy to L-arginine.
  • Patients with Asthma.
  • Hepatic dysfunction: serum Alanine Aminotransferase (ALT) > 3X upper value.
  • Renal dysfunction: Creatinine level greater than or equal to 1.2 mg/dl.
Contacts and Locations
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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): NCT05470998


Contacts
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Contact: dalia A gomaa 01063410525 dalia_gomaa@pharm.tanta.edu.eg

Locations
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Egypt
Tanta university Recruiting
Tanta, Other (Non U.s.), Egypt
Contact: dalia A gomaa    01063410525    dalia_gomaa@pharm.tanta.edu.eg   
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: dalia A gomaa Tanta University
More Information
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Responsible Party: Dalia Abdelhamid Gomaa, demonstrator at clinical pharmacy department, faculty of pharmacy, Tanta University
ClinicalTrials.gov Identifier: NCT05470998    
Other Study ID Numbers: L-Arginine 2021
First Posted: July 22, 2022    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn