Clinical Trials Directory

Trials / Completed

CompletedNCT01628770

Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia

Iron Isomaltoside 1000 (Monofer)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
271 (actual)
Sponsor
Dow University of Health Sciences · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

Summary

The investigators hypothesized that both isomaltoside 1000 (Monofer), and oral iron preparation will be equally effective in correction of postpartum iron deficiency anemia.

Detailed description

Iron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. This preparation has been used for treatment of anemia in patients with chronic renal disease, gastrointestinal disorders, anemia of malignancy and in gynecological disorders. It does not require a test dose to be given before total dose, nor does it require any premedication. It can be given in a dose of 20mg/kg. The drug has been licensed for use in Europe in 2009. It has been used for treatment of anemia in patients with chronic renal disease, inflammatory bowel disease and in anemia due to malignancies

Conditions

Interventions

TypeNameDescription
DRUGIron isomaltoside 1000Iron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. It can be given in a dose of 20mg/kg body weight.
DRUGFerrous sulphate200mg twice daily

Timeline

Start date
2012-05-01
Primary completion
2012-12-01
Completion
2012-12-01
First posted
2012-06-27
Last updated
2016-08-03

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT01628770. Inclusion in this directory is not an endorsement.