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:

MedlinePlus related topics: 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

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 Anemia, Hypochromic Iron Metabolism Disorders Iron Hematologic Diseases	Metabolic Diseases Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs Trace Elements

ClinicalTrials.gov processed this record on February 27, 2015

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