Iron Substitution After Upper Gastro-Intestinal Bleeding

Comparison of the Efficacy of Compliant Oral Iron Treatment (FerroDuretter ®) for 3 Months After Discharge Versus Single-dose of Intravenous Iron (Ferinject ®) Before Discharge in Patients With Acute Bleeding From Upper Gastrointestinal Tract. A Double Blinded Randomized Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00978575

Enrollment

Registered

2009-09-17

Start date

2010-04-30

Completion date

2013-04-30

Last updated

2013-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Gastrointestinal Hemorrhage

Keywords

Iron treatment, Upper gastrointestinal bleeding

Brief summary

The trial is a double-blind randomized trial designed to examine whether compliant iron therapy (intravenous or oral) for 3 months after discharge increases hemoglobin levels more and faster than no treatment - in patients with acute bleeding from upper gastrointestinal tract. The trial will include 126 patients at Aarhus University Hospital. In addition to efficacy assessment quality of life assessment and health economic calculations between the treatments will be compared.

Interventions

DRUGferricarboxymaltose

Single dose of maximum 1000 mg ferricarboxymaltose intravenous

DRUGFerrosulfate

200mg daily for 12 weeks

DRUGPlacebo

100 mg isotonic sodium and 2 placebo tablets daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Acute upper gastrointestinal bleeding * Anemia

Exclusion criteria

* Liver disease * Terminal cancer * Kidney disease * variceal bleeding * Pregnancy

Design outcomes

Primary

Measure	Time frame
haemoglobin	13 weeks

Secondary

Measure	Time frame
Quality of life Health economics	13 weeks, 6 and 12 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026