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Out Come Study To Define Laboratory Parameters That Are Best Suited to Diagnose Functional Iron Deficiency (SFIDS)

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ClinicalTrials.gov Identifier: NCT00495781
Recruitment Status : Completed
First Posted : July 3, 2007
Last Update Posted : July 3, 2007
Sponsor:
Collaborator:
Viollier Inc.
Information provided by:
Spital Zollikerberg

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of the study is to define laboratory parameters which are best suited to diagnose functional iron deficiency. Functional iron deficiency is a condition where - due to the lack of iron bioavailability - the patient suffers from symptoms such as fatigue and weakness, or his/her capacity to produce red blood cells is reduced.

Condition or disease Intervention/treatment Phase
Functional Iron Deficiency Procedure: %-hypo (laboratory parameter, functional iron deficiency) Procedure: CHr (laboratory parameter, functional iron deficiency) Procedure: RET-HE (laboratory parameter, functional iron deficiency) Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: Swiss Functional Iron Deficiency Study
Study Start Date : October 2004
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change in Hemoglobin [ Time Frame: 12 months ]
  2. Costs = erythropoietin/darbepoetin prescribed [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Changes in soluble transferrin receptor [ Time Frame: 12 months ]
  2. Changes in transferrin saturation [ Time Frame: 12 months ]
  3. changes in ferritin [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • renal anemia, glomerular filtration rate < 10 ml/min
  • therapy with either erythropoietin or darbepoetin
  • dialysis patients
  • therapy with iron

Exclusion Criteria:

  • cancer
  • autoimmune diseases
  • chronic inflammation
  • liver disease
  • thalassemia, and other causes of anemia (except for renal anemia and iron deficiency anemia)
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495781


Locations
Switzerland
Spital Zollikerberg
Zollikerberg, Zürich, Switzerland, 8125
Sponsors and Collaborators
Spital Zollikerberg
Viollier Inc.
Investigators
Principal Investigator: Boris E Schleifenbaum, MD Viollier Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00495781     History of Changes
Other Study ID Numbers: SFIDS-2004
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: July 3, 2007
Last Verified: July 2007

Keywords provided by Spital Zollikerberg:
functional iron deficiency
renal anemia
dialysis
erythropoietin
darbepoetin

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
 Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs