Ferric Polymaltose Complex (Ferose) in Treatment of Iron Deficiency and Iron Deficiency Anemia with Pregnancy

Not Applicable

Completed

• Conditions: Iron deficiency with pregnancy; Iron deficiency anemia; Reproductive Health and Childbirth - Antenatal care; Blood - Anaemia

• Registration Number: ACTRN12619000230156
• Lead Sponsor: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.

Brief Summary

Results: The pre-treatment ferritin, and hemoglobin significantly increased, 3-months` after ferric polymaltose (FPM (Ferose®)) treatment. In addition, the mean pre-treatment red-blood cells volume and red-blood cells hemoglobin significantly increased 3-months` after ferric polymaltose (FPM (Ferose®)) treatment. Conclusion. The ferric polymaltose (Ferose®) is an effective therapeutic option for treatment of iron deficiency and iron deficiency anemia during pregnancy with high safety profile, and low side effects. The superior tolerability of ferric polymaltose is an important advantage because compliance to oral iron is the main obstacle toward effective treatment of iron deficiency and iron deficiency anemia.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-18
• Study Completion: 2020-06-18
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 122

Inclusion Criteria

Inclusion criteria include; pregnant women equal or more than 20 years old, 14-26 weeks` gestation with serum ferritin less than 15 ug/l and hemoglobin less than or equal 10 gm/dl.

Exclusion Criteria

Exclusion criteria include; pregnant women with intolerance or hypersensitivity to oral iron and/or anemia other than iron deficiency anemia and/or received blood transfusion during current pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of the ferric hydroxide-polymaltose complex tablets in treatment of iron deficiency with pregnancy, using the serum ferritin assay (laboratory test). [Every 2-4 weeks for 4 months post-enrolment (primary endpoint).];The efficacy of the ferric hydroxide-polymaltose complex tablets in treatment of iron deficiency anaemia with pregnancy, Correction of iron deficiency anaemia after the treatment detected using complete blood picture (laboratory test).<br>Complete blood picture contains; serum haemoglobin. mean corpuscular volume and mean corpuscular haemoglobin.[Every 2-4 weeks for 4 months post-enrolment (primary endpoint).]

Secondary Outcome Measures

Name	Time	Method
The side effects related to ferric hydroxide-polymaltose complex tablets using the medication related side effects questionnaire specially for this study.<br>Example of the ferric hydroxide-polymaltose complex side effects: metallic taste, gatrointestinal upset and constipation. <br><br>[Assessed every 2-4 weeks for 4 months post-enrolment.]