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Pilot Study of Fructose for Sickle Cell Crisis

This study has been completed.
Sponsor:
Collaborator:
Rehabilitation Institute of Chicago
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004797
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
History of Changes
  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

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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
National Center for Research Resources (NCRR)
Rehabilitation Institute of Chicago
Investigators
Study Chair: David Green Rehabilitation Institute of Chicago
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on May 16, 2013