Actively Recruiting

Phase 2
Age: 4Years - 21Years
All Genders
NCT06635902

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

Led by Suvankar Majumdar · Updated on 2026-04-13

99

Participants Needed

1

Research Sites

218 weeks

Total Duration

On this page

Sponsors

S

Suvankar Majumdar

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 4Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of sickle cell disease (all genotypes)
  • Age between 4 and 21 years
  • Currently experiencing a sickle cell vaso-occlusive pain episode requiring hospitalization and parenteral opioid therapy
  • Able to start study drug/placebo within 12 hours of first parenteral opioid dose in the Emergency Department
Not Eligible

You will not qualify if you...

  • Pain lasting more than 3 days at enrollment
  • More than 9 hospitalizations in the previous year
  • Hospitalization due to other sickle cell complications like splenic or hepatic sequestration, stroke, or transient ischemic attack
  • History of opioid use disorder, chronic pain, or daily opioid use
  • Severe anemia with hemoglobin less than 6 g/dL
  • Pregnant or breastfeeding females
  • Elevated liver enzymes (alanine/aspartate transferase more than twice the upper normal limit for age)
  • Elevated serum creatinine above age-specific limits
  • Presence of acute chest syndrome, sepsis, bacterial infection, or hemodynamic instability
  • Current use of L-glutamine
  • History of allergic reaction to L-citrulline products

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's National Hospital

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

Actively Recruiting

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Research Team

J

Jillian Baker, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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