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Can a natural amino acid shorten sickle cell pain crises? new trial aims to find out

NCT ID NCT06635902

Symptom relief Sponsor: Suvankar Majumdar Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a natural substance called citrulline, given through an IV, can help children and teens with sickle cell disease recover faster from severe pain episodes. About 99 hospitalized participants aged 4 to 21 will receive either citrulline or a placebo for 16 hours. Researchers will measure how long the pain lasts and how much pain medicine is needed, while also checking for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 99 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

sickle cell disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sickle cell disease Vaso-occlusive pain episode

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's National Hospital

    RECRUITING

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

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