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L-Citrulline for Sickle Cell Pain Crisis

This study is testing if intravenous L-citrulline can help treat acute pain during a vaso-occlusive pain episode (VOE) in people with sickle cell disease who are hospitalized. Researchers want to see if L-citrulline can shorten how long you experience pain during your hospital stay and what side effects might occur. You would receive either a high dose of L-citrulline, a low dose of L-citrulline, or a placebo (a substance with no medicine) for 16 hours. The study aims to enroll 99 participants, aged 4 to 21 years, who are currently hospitalized for a sickle cell pain crisis. The current recruitment status is unclear.

Study design
This is a Phase 2, randomized, double-blind, placebo-controlled study involving about 99 participants. You would be randomly assigned to receive one of two doses of L-citrulline or a placebo.
What's involved
You would receive baseline tests and intravenous L-citrulline for 16 hours during your hospital stay. After discharge, you would have a follow-up clinic visit about 30 days later for checkup and tests.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to 30 days after starting the study drug, with a clinic visit around that time for checkup and tests.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06635902

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

Recruiting
PHASE2Ages 4–21InterventionalTreatment
Suvankar Majumdar
~99 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:L-citrullinePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time-to-crisis resolution
Measured over Baseline to 30 days

Conditions

Sickle Cell Disease
Vaso-occlusive Pain Episode

Explore related trials

Sickle Cell Disease

Where it's being run

1 sites across 1 states
District of Columbia1

Study leadership

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

Who to contact

Jillian Baker, RN
[email protected]
202-476-1311
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Sickle cell disease (all genotypes)
Patients with sickle cell disease ages 4 to 21 years old
Presence of sickle cell vaso-occlusive pain episode requiring hospitalization and parenteral opioid therapy
Able to randomize to study drug/placebo within 12 hours of first dose of parenteral opioid in the Emergency Department

Exclusion

Current pain lasting \>3 days.
\>9 hospitalizations in the prior year
Presence of any other complication related to sickle cell disease requiring the hospitalization such as splenic sequestration, hepatic sequestration, stroke, transient ischemic attack, etc.
History of opioid use disorder, chronic pain or medical regimen requiring daily opioid use.
Severe anemia (hemoglobin \<6g/dL)
Pregnant (as confirmed by a positive urine pregnancy test) or lactating female.
Alanine/aspartate transferase \>2x upper limit of normal laboratory range for age.
Subject has the following serum creatinine:
Age 4 to 13 years \> 0.9 mg/dL
Age 14 to 17 years 1.0 mg/dL
Age ≥18 years \>1.5mg/dL
Presence of acute chest syndrome, sepsis, bacterial infection, hemodynamic instability
Use of L-glutamine
History of allergic reaction to L-citrulline products

What this trial measures

  • Time-to-crisis resolutionBaseline to 30 days

    Change in time-to-crisis resolution as defined by the time (in hours) from first dose of intravenous study drug or placebo to the time of last dose of intravenous opioid during hospitalization