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Pilot Study of Fructose for Sickle Cell Crisis
This study has been completed.
First Received: February 24, 2000   Last Updated: June 23, 2005   History of Changes
Sponsors and Collaborators: National Center for Research Resources (NCRR)
Rehabilitation Institute of Chicago
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004797
  Purpose

OBJECTIVES: I. Evaluate the efficacy and tolerability of fructose administered every 6 hours for up to 72 hours to patients in active sickle cell crisis. II. Obtain tolerability information in selected patients treated with fructose for more than 72 hours.


Condition Intervention
Sickle Cell Anemia
Drug: fructose
Drug: placebo

Genetics Home Reference related topics: sickle cell disease
MedlinePlus related topics: Anemia Sickle Cell Anemia
Drug Information available for: Fructose
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 20
Study Start Date: August 1995
Detailed Description:

PROTOCOL OUTLINE: In the first part of the study, patients are block-randomized (3:1) to a single intravenous dose of fructose or placebo. The dose of fructose is escalated in each successive group after tolerability data are evaluated.

In the second part of the study, patients are randomly assigned (1:1) to fructose or placebo administered intravenously every 6 hours for 72 hours. The dose of fructose is the highest well-tolerated dose determined in Study 1 or the most tolerated dose for the patient. Patients who just completed Study 1 may participate if they are clearly in a separate crisis and continue to meet entry criteria.

Patients whose symptoms persist for more than 72 hours after fructose or placebo are eligible to receive additional fructose every 6 hours until symptoms subside.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Sickle cell crisis requiring hospital admission Crisis began at least 12 hours prior to admission Medical records documenting sickle cell disease and previous crisis requiring hospital visit during the last 24 months available at study site No thalassemia No complex hemoglobinopathy involving thalassemia and sickle cell disease

--Patient Characteristics-- Renal: Creatine no greater than 2.2 mg/dL No requirement for regular dialysis Other: Weight above or below 30% of ideal body weight No fructose intolerance No insulin-dependent diabetes No HIV seropositivity No acquired immune deficiency syndrome (AIDS) or AIDS-related illness No general anesthetic for 7 days prior to and 2 days following entry Primary language allows communication with study staff Demonstration of ability to read and understand pain scales required Ability to identify crisis starting time accurately, i.e., to within 6 hours

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004797

Sponsors and Collaborators
Rehabilitation Institute of Chicago
Investigators
Study Chair: David Green Rehabilitation Institute of Chicago
  More Information

No publications provided

Study ID Numbers: 199/11941, NU-573
Study First Received: February 24, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00004797     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
disease-related problem/condition
genetic diseases and dysmorphic syndromes
hematologic disorders
pain
rare disease
sickle cell anemia

Study placed in the following topic categories:
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Rare Diseases
Anemia
Sickle Cell Anemia
Anemia, Hemolytic
Pain
Hemoglobinopathy
Anemia, Sickle Cell

Additional relevant MeSH terms:
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Anemia
Anemia, Hemolytic
Anemia, Sickle Cell

ClinicalTrials.gov processed this record on May 07, 2009