Out Come Study To Define Laboratory Parameters That Are Best Suited to Diagnose Functional Iron Deficiency (SFIDS)
This study has been completed.
Sponsor:
Spital Zollikerberg
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
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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 (Adult, Senior) |
| 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
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
| 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 |
ClinicalTrials.gov processed this record on September 28, 2016