NCT00495781

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2007

Completed
Last Updated

July 3, 2007

Status Verified

July 1, 2007

First QC Date

July 2, 2007

Last Update Submit

July 2, 2007

Conditions

Functional Iron Deficiency

Keywords

functional iron deficiencyrenal anemiadialysiserythropoietindarbepoetin

Outcome Measures

Primary Outcomes (2)

  • Change in Hemoglobin

    12 months

  • Costs = erythropoietin/darbepoetin prescribed

    12 months

Secondary Outcomes (3)

  • Changes in soluble transferrin receptor

    12 months

  • Changes in transferrin saturation

    12 months

  • changes in ferritin

    12 months

Interventions

%-hypo (laboratory parameter, functional iron deficiency)PROCEDURE
CHr (laboratory parameter, functional iron deficiency)PROCEDURE
RET-HE (laboratory parameter, functional iron deficiency)PROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • renal anemia, glomerular filtration rate \< 10 ml/min
  • therapy with either erythropoietin or darbepoetin
  • dialysis patients
  • therapy with iron

You may not qualify if:

  • cancer
  • autoimmune diseases
  • chronic inflammation
  • liver disease
  • thalassemia, and other causes of anemia (except for renal anemia and iron deficiency anemia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spital Zollikerberg

Zollikerberg, Canton of Zurich, 8125, Switzerland

Location

MeSH Terms

Interventions

Peroxisomal Biogenesis Factor 2

Intervention Hierarchy (Ancestors)

PeroxinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsMembrane Proteins

Study Officials

  • Boris E Schleifenbaum, MD

    Viollier Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 2, 2007

First Posted

July 3, 2007

Study Start

October 1, 2004

Study Completion

May 1, 2006

Last Updated

July 3, 2007

Record last verified: 2007-07

Locations

CH(1)