Recruiting
Phase 2

L-Citrulline

Sponsor:

Suvankar Majumdar

Code:

NCT06635902

Conditions

Sickle Cell Disease

Vaso-occlusive Pain Episode

Eligibility Criteria

Sex: All

Age: 4 - 21

Healthy Volunteers: Not accepted

Interventions

L-citrulline

Placebo

L-citrulline

Study Details

Brief 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

Sickle Cell Disease

Vaso-occlusive Pain Episode

Study ID

NCT06635902

Start date

Dec 22, 2024

Status verified date

Apr, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

99 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low dose intravenous L-citrulline

experimental: High dose intravenous L-citrulline

placebo comparator: Placebo

Interventions

L-citrulline

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

Placebo

Isotonic normal saline

L-citrulline

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

Primary outcome measure

  • Time-to-crisis resolution [ Time Frame: Baseline to 30 days ]

Central Contacts and Locations

Central contacts

Jillian Baker, RN

202-476-1311jbaker5@childrensnational.org

Locations

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Jillian Baker, RN

202-476-1311jbaker5@childrensnational.org

Principal Investigator:

Suvankar Majumdar, MD

More Information

Sponsor

Suvankar Majumdar

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • sickle cell disease
  • sickle cell pain crisis
  • citrulline

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Suvankar Majumdar on 2026-04-13.