Iron Substitution in Blood Donors

NCT01519830 | Completed Phase 4

• 2 other identifiers: 010/11Swissmedic 2011DR3145
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

Brief Summary

Depletion of iron stores is frequently observed in regular blood donors, but effects of iron deficiency on general health is not well studied. Recent studies in women suffering of fatigue suggest iron deficiency without concomitant anemia as a common cause of these complaints. Provided the same is true in healthy subjects, substitution of intravenous iron might result in an improvement of general well being in iron depleted blood donors. Healthy regular blood donors will be screened for low storage iron. Qualifying subjects will be invited to participate in a randomized, placebo-controlled trial with substitution of intravenous iron or placebo (saline solution). Differences in subjectively felt fatigue and other factors of general health and well being will be assessed. If an improvement of such factors can be shown after iron replacement, relevant concerns about artificially lowering iron stores by repeated phlebotomies will arise and changes of monitoring and substitution policies in blood banking might have to be discussed.

Conditions

Fatigue

Keywords

Anemia, Iron-Deficiency; Blood Donors

Outcome Measures

Primary Outcomes (1)

• Difference of fatigue on a 10 point numeric scale after intravenous substitution of iron or placebo

  measured by questionnaire

  6 weeks

Secondary Outcomes (3)

• Change of fatigue after intravenous substitution of iron

  6 weeks

• Improvement of general wellbeing

  6 weeks

• Number of patients with adverse events of different grades

  6 weeks

Study Arms (2)

Verum

EXPERIMENTAL

Iron Carboxymaltose (Ferinject)

Drug: Iron carboxymaltose (Ferinject)

Placebo

PLACEBO COMPARATOR

0.9% NaCl solution

Drug: Placebo

Interventions

Iron carboxymaltose (Ferinject) DRUG

Intravenous iron

Verum

Placebo DRUG

0.9% NaCl solution

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Serum-Ferritin 50 microg/l
• Eligibility for blood donation
• At least one prior blood donation

You may not qualify if:

• Anemia
• Known intolerability of intravenous iron
• History of anaphylactic reactions
• Active systemic infections
• Signs of chronic bleeding
• Known iron overload
• Lactation
• Pregnancy
• Any disease associated with increased fatigue
• Medication associated with increased fatigue

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Blutspendedienst SRK Bern AG, 3008 Bern, Switzerland: collaborator
• University of Bern: collaborator
• Humanitäre Stiftung des Schweizerischen Roten Kreuzes, 3011 Bern, Switzerland: collaborator

Study Sites (1)

Department of Hematology, Bern University Hospital

Bern, Canton of Bern, CH-3010, Switzerland

Location

MeSH Terms

Conditions

Fatigue; Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Peter Keller, MD

  Department of Hematology, Bern University Hospital, Switzerland

  STUDY CHAIR

• Bernhard Lämmle, MD, Prof.

  Department of Hematology, Bern University Hospital, Switzerland

  STUDY CHAIR

• Stefano Fontana, MD

  Blutspendedienst SRK Bern AG, Bern, Switzerland

  STUDY CHAIR

• Peter Jüni, MD, Prof.

  Institut für Sozial- und Präventivmedizin, Universität Bern, Switzerland

  STUDY CHAIR

• Roland von Känel, MD, Prof.

  Kompetenzbereich für Psychosomatische Medizin, University Hospital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 27, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

CH (1)