Comparison of Ferric Carboxymaltose and IV Iron Sucrose

Not Applicable

Completed

• Conditions: Anemia
• Interventions: Drug: Intravenous Ferric Carboxymaltose; Drug: Intravenous Iron Sucrose

• Registration Number: NCT07115121
• Lead Sponsor: Muhammad Aamir Latif

Brief Summary

Literature search has shows that both ferric carboxymaltose and iron sucrose complex are equally effective. Unfortunately, local data addressing this issue is scarce. To get further local data, the current study was planned with the objective to compare the mean change in hemoglobin with ferric carboxymaltose and IV iron sources in anemic antenatal patients in our local population.

Detailed Description

It was hypothesized that there was a difference in mean change in hemoglobin with ferric carboxymaltose as compared to IV iron sources in anemic antenatal patients. The findings of the study would be a valuable addition to the existing stats, and if the hypothesis stands correct, a large number of women of reproductive age would benefit from effective iron replacement therapy, with a comparatively low incidence of side effects.

Study Timeline

• Study Start: 2025-02-02
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31
• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Pregnant women
• Aged 18 to 40 years
• Presented with anemia
• Any parity
• Gestational age < 12 weeks on LMP

Exclusion Criteria

• Females with a history of hypertension
• Type II diabetes mellitus
• Gestational diabetes mellitus
• Ischemic heart disease
• Endocrine disorder
• Hematological disorders (hemophilia, leukemia, lymphoma, or myeloma)
• History of taking iron-lowering drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferric Carboxymaltose-Group	Intravenous Ferric Carboxymaltose	Patients were given ferric carboxymaltose as a maximum single dose of 1000 mg diluted in 250 mL of sterile 0.9% normal saline as a slow infusion over 45 minutes.
Iron Sucrose-Group	Intravenous Iron Sucrose	Patients received intravenous injections of iron sucrose complex, which contained 200 mg of elemental iron (equivalent to 2 ampoules of 5 ml), mixed in 100 ml of 0.9% normal saline and infused over a period of 30 minutes every other day for up to 5 doses.

Primary Outcome Measures

Name	Time	Method
Increase in hemoglobin	12 weeks	Baseline hemoglobin was subtracted from post-treatment hemoglobin to assess increase in the hemoglobin

Trial Locations

Locations (1)

Bahawal Victoria Hospital; 🇵🇰 Bahawalpur, Punjab, Pakistan