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Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial

NCT ID: NCT01796678

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2007-06-30

Brief Summary

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Vaso-occlusion contributes significantly to morbidity in sickle cell disease (SCD). Vaso-occlusive painful episodes (VOE) are common and debilitating, causing the majority of emergency department visits. Currently efforts to treat painful episodes with use of non-steroidal pain relievers and intravenous narcotics offer symptomatic relief only, without targeting the underlying mechanisms of vaso-occlusion.Investigators have found that an arginine deficiency and low NO bioavailability occurs during painful events in SCD. Since arginine is the obligate substrate for NO production, and an acute deficiency is associated with VOE, investigators hypothesized that arginine supplementation may be a safe and beneficial treatment for sickle cell pain.

Detailed Description

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Conditions

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Vaso-occlusive Pain Episodes

Keywords

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sickle cell disease vaso-occlusive pain episodes arginine nitric oxide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arginine

100 mg/kg T.I.D 3x a day IV or PO

Group Type EXPERIMENTAL

Arginine

Intervention Type DRUG

Placebo

Saline or sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline or Sugar pill was given as placebo

Interventions

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Arginine

Intervention Type DRUG

Placebo

Saline or Sugar pill was given as placebo

Intervention Type DRUG

Other Intervention Names

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L-arginine, L-arginine-HCL

Eligibility Criteria

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Inclusion Criteria

* Established Diagnosis of Sickle Cell Disease(SS,SC,S-beta thal)
* Admitted to Hospital for pain
* Pain requiring hospitalization for parenteral narcotics, not attributable to non-sickle cell causes
* \>3 year and older

Exclusion Criteria

* Hemoglobin less than 5gm/dL or immediate need for red cell transfusion
* Hepatic Dysfunction: increased in SGPT to \>2x normal value
* Renal Dysfunction: increased in creatinine to \>2x normal value or \>1.5
* Mental status or neurological changes
* Pregnancy
* \>10 Hospitalizations per year or history of dependance to narcotics
* Inability to take oral medications or allergy to arginine
* Inability to use a PCA device
* \< 3 years of age
Minimum Eligible Age

3 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudia R Morris, MD

Role: PRINCIPAL_INVESTIGATOR

Childrens Hospital Oakland

Locations

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Childrens Hospital Research Center Oakland

Oakland, California, United States

Site Status

Countries

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United States

References

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Morris CR, Kuypers FA, Lavrisha L, Ansari M, Sweeters N, Stewart M, Gildengorin G, Neumayr L, Vichinsky EP. A randomized, placebo-controlled trial of arginine therapy for the treatment of children with sickle cell disease hospitalized with vaso-occlusive pain episodes. Haematologica. 2013 Sep;98(9):1375-82. doi: 10.3324/haematol.2013.086637. Epub 2013 May 3.

Reference Type RESULT
PMID: 23645695 (View on PubMed)

Other Identifiers

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HL 14386-05

Identifier Type: -

Identifier Source: org_study_id