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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000230156
Enrollment
122
Registered
2019-02-18
Start date
2019-08-03
Completion date
2020-04-03
Last updated
2021-12-27

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

Conditions

None listed

Brief summary

Pregnant women with iron deficiency (ferritin <15 ug/l) and iron deficiency anemia with pregnancy (haemoglobin less than 10 gm/dl (7-10 gm/dl mild to moderate) will be included in this study after informed consent. Diagnosis of iron deficiency based on serum ferritin (ug/l) and iron deficiency anemia based on; serum ferritin (ug/l), hemoglobin concentration (gm/dl), red blood cells-mean corpuscular volume (MCV) and hemoglobin (MCH). Studied women will be treated with the ferric hydroxide-polymaltose complex tablets for correction of iron deficiency and iron deficiency anemia for 3 months. The pre-treatment ferritin, hemoglobin, red blood cells red blood cells-mean corpuscular volume (MCV) and hemoglobin (MCH) will be compared by the 3 months` post-treatment values to evaluate the efficacy of ferric hydroxide-polymaltose complex tablets in treatment of iron deficiency and iron deficiency anemia with pregnancy in the same group of women.

Interventions

Pregnant women with iron deficiency (ferritin <15 ug/l) and iron deficiency anemia with pregnancy (haemoglobin less than 10 gm/dl (7-10 gm/dl mild to moderate)) will be included in this study after informed consent. Diagnosis of iron deficiency based on serum ferritin (ug/l) and iron deficiency anemia based on; serum ferritin (ug/l), hemoglobin concentration (gm/dl), red blood cells-mean corpuscular volume (MCV) and hemoglobin (MCH). Studied women will be treated with the (Ferose tablets) ferr

Pregnant women with iron deficiency (ferritin <15 ug/l) and iron deficiency anemia with pregnancy (haemoglobin less than 10 gm/dl (7-10 gm/dl mild to moderate)) will be included in this study after informed consent. Diagnosis of iron deficiency based on serum ferritin (ug/l) and iron deficiency anemia based on; serum ferritin (ug/l), hemoglobin concentration (gm/dl), red blood cells-mean corpuscular volume (MCV) and hemoglobin (MCH). Studied women will be treated with the (Ferose tablets) ferric hydroxide-polymaltose complex tablets (3 times daily) for correction of iron deficiency and iron deficiency anemia for 3 months. Each tablet of Ferose contains 100 mg of ferric hydroxide-polymaltose complex. The adherence to the treatment will be checked by the empty tablet package and laboratory test to check the efficacy of the iron treatment in treating iron deficiency and iron deficiency anemia using the laboratory parameters; serum ferritin (ug/l), hemoglobin concentration (gm/dl), red blood cells-mean corpuscular volume (MCV) and hemoglobin (MCH). The pre-treatment ferritin, hemoglobin, red blood cells red blood cells-mean corpuscular volume (MCV) and hemoglobin (MCH) will be compared by the 3 months` post-treatment values to evaluate the efficacy of ferric hydroxide-polymaltose complex tablets in treatment of iron deficiency and iron deficiency anemia with pregnancy in the same study group of women.

Sponsors

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026