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Intravenous L-Citrulline for Vaso-occlusive Pain Episode in Sickle Cell Disease

NCT06635902 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2026-04-13

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if intravenous citrulline works to treat acute pain in hospitalized patients with sickle cell disease. It will also learn about the safety of intravenous citrulline. The main questions it aims to answer are:

* Does intravenous citrulline decrease the duration of sickle cell pain during hospitalization
* What medical problems do participants have when taking intravenous citrulline? Researchers will compare intravenous citrulline to a placebo (a look-alike substance that contains no drug) to see if intravenous citrulline works to treat acute pain.

Participants will:

* Receive baseline tests and intravenous citrulline for 16 hours during the hospital stay
* After hospital discharge, visit the clinic in about 30 days for checkup and tests

Conditions

Interventions

DRUG

L-citrulline

Intravenous L-citrulline (50 mg/kg + 9mg/kg/hr.) for 16 hours

OTHER

Placebo

Isotonic normal saline

DRUG

L-citrulline

Intravenous L-citrulline (25 mg/kg + 9mg/kg/hr.) for 16 hours

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Suvankar Majumdar

    lead OTHER

Principal Investigators

  • Suvankar Majumdar, MD · Children's National Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-22
Primary Completion
2028-06-30
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06635902 on ClinicalTrials.gov