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Arginine Therapy for Sickle Cell Disease Pain

NCT02536170 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2023-09-06

Study results available
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Summary

The aim of this study is to determine whether giving extra arginine, a simple amino acid, to patients with sickle cell disease seeking treatment for a pain crisis (vaso-occlusive painful events (VOE) will decrease pain scores, decrease the need for pain medications or decrease length of hospital stay or emergency department visit. Funding Source - FDA OOPD.

Conditions

Interventions

DRUG

L-arginine

L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.

DRUG

L-arginine Loading Dose

One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg

OTHER

Placebo

Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.

Sponsors & Collaborators

  • Children's Healthcare of Atlanta

    collaborator OTHER

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Claudia Morris, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2021-02-21
Completion
2021-02-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02536170 on ClinicalTrials.gov