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

Primary Purpose

Sickle Cell Disease

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
L-Arginine
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tanta universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control group

L-Arginine group

Arm Description

this group will include 25 patients who will receive their standard therapy for 3 months

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

Outcomes

Primary Outcome Measures

change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography
patients will undergo Color Doppler Echocardiography to assess tricuspid regurgitant jet velocity (TRJV) at baseline and after 3 months

Secondary Outcome Measures

change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP)
Blood samples will be collected at baseline and after 3 months
change in serum level of L-Arginine
Blood samples will be collected at baseline and after 3 months
change in serum level of Asymmetric Dimethyl Arginine (ADMA)
Blood samples will be collected at baseline and after 3 months
change in serum level of Nitric Oxide
Blood samples will be collected at baseline and after 3 months

Full Information

First Posted
July 17, 2022
Last Updated
July 20, 2022
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05470998
Brief Title
L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
this group will include 25 patients who will receive their standard therapy for 3 months
Arm Title
L-Arginine group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
L-Arginine
Intervention Description
L-Arginine 1000 mg free form, rapid release capsules
Primary Outcome Measure Information:
Title
change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography
Description
patients will undergo Color Doppler Echocardiography to assess tricuspid regurgitant jet velocity (TRJV) at baseline and after 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP)
Description
Blood samples will be collected at baseline and after 3 months
Time Frame
3 months
Title
change in serum level of L-Arginine
Description
Blood samples will be collected at baseline and after 3 months
Time Frame
3 months
Title
change in serum level of Asymmetric Dimethyl Arginine (ADMA)
Description
Blood samples will be collected at baseline and after 3 months
Time Frame
3 months
Title
change in serum level of Nitric Oxide
Description
Blood samples will be collected at baseline and after 3 months
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
dalia A gomaa
Phone
01063410525
Email
dalia_gomaa@pharm.tanta.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dalia A gomaa
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta university
City
Tanta
State/Province
Other (Non U.s.)
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dalia A gomaa
Phone
01063410525
Email
dalia_gomaa@pharm.tanta.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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