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

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05470998
Collaborator
(none)
50
1
2
33.2
1.5

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 25, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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

Primary Outcome Measures

  1. change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography [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) [3 months]

    Blood samples will be collected at baseline and after 3 months

  2. change in serum level of L-Arginine [3 months]

    Blood samples will be collected at baseline and after 3 months

  3. change in serum level of Asymmetric Dimethyl Arginine (ADMA) [3 months]

    Blood samples will be collected at baseline and after 3 months

  4. change in serum level of Nitric Oxide [3 months]

    Blood samples will be collected at baseline and after 3 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Tanta university Tanta Other (Non U.s.) Egypt

Sponsors and Collaborators

  • Tanta University

Investigators

  • Principal Investigator: dalia A gomaa, Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jul 22, 2022
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 22, 2022