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

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

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


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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495781

Spital Zollikerberg
Zollikerberg, Zürich, Switzerland, 8125
Sponsors and Collaborators
Spital Zollikerberg
Viollier Inc.
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

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

ClinicalTrials.gov processed this record on April 15, 2014