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

Conditions

• Sickle Cell Disease
• Vaso-occlusive Pain Episode

Eligibility Criteria

Sex

ALL

Age

4 Years - 21 Years

Healthy Volunteers

Not accepted

Interventions

• L-citrulline — DRUG
  Intravenous L-citrulline (50 mg/kg + 9mg/kg/hr.) for 16 hours
• Placebo — OTHER
  Isotonic normal saline
• L-citrulline — DRUG
  Intravenous L-citrulline (25 mg/kg + 9mg/kg/hr.) for 16 hours

Study Details

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

Key Dates

Start date

Dec 22, 2024

Status verified

Apr 2026

Primary completion

Jun 30, 2028

Completion

Mar 31, 2029

Study Design

Enrollment

99 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Low dose intravenous L-citrulline
• Experimental: High dose intravenous L-citrulline
• Placebo Comparator: Placebo

Primary Outcome Measure

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

Central Contacts

• Jillian Baker, RN
  202-476-1311
  [email protected]

Locations (1)

Find similar trials in Washington D.C., DC

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