Trial record 4 of 304 for:    iron-deficiency anemia

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

This study has been completed.
Sponsor:
Collaborator:
Viollier Inc.
Information provided by:
Spital Zollikerberg
ClinicalTrials.gov Identifier:
NCT00495781
First received: July 2, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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 Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Swiss Functional Iron Deficiency Study

Resource links provided by NLM:


Further study details as provided by Spital Zollikerberg:

Primary Outcome Measures:
  • Change in Hemoglobin [ Time Frame: 12 months ]
  • Costs = erythropoietin/darbepoetin prescribed [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Changes in soluble transferrin receptor [ Time Frame: 12 months ]
  • Changes in transferrin saturation [ Time Frame: 12 months ]
  • changes in ferritin [ Time Frame: 12 months ]

Enrollment: 77
Study Start Date: October 2004
Study Completion Date: May 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00495781     History of Changes
Other Study ID Numbers: SFIDS-2004
Study First Received: July 2, 2007
Last Updated: July 2, 2007
Health Authority: Switzerland: Kantonale Ethische Kommission, Zürich

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014