Out Come Study To Define Laboratory Parameters That Are Best Suited to Diagnose Functional Iron Deficiency - Full Text View

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

This study has been completed.

First Received on July 2, 2007. No Changes Posted

Sponsor:	Spital Zollikerberg
Collaborator:	Viollier Inc.
Information provided by:	Spital Zollikerberg
ClinicalTrials.gov Identifier:	NCT00495781

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:

MedlinePlus related topics: Anemia Iron

U.S. FDA Resources

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

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 February 09, 2012