None listed
Conditions
Brief summary
Pregnant women with pregnancy associated iron deficiency anemia and hemoglobin less than or equal 10 gm/dl (8-10 gm/dl) will included in this study, to receive either heme-bound iron (HIO) Optifer tablets twice daily (study group) or Trihmeic 350 mg oral ferrous fumarate once daily (control group) for at least 3 or more months for correction of anemia. Iron deficiency anemia will be diagnosed by the following parameters; hemoglobin concentration (gm/dl), serum ferritin (ug/l), mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH). The Optifer and Trihemic tablets efficacy will be checked by comparing the pre-treatment hemoglobin, ferritin, mean corpuscular volume and mean corpuscular hemoglobin by the 3 months` post-treatment values. Primary outcome measures; the efficacy of the Optifer compared to ferrous fumarate (Trihmeic) in treatment of pregnancy associated iron deficiency anemia. While the secondary outcome measures; the tolerability and the side effects related to the Optifer and Trihmeic tablets.
Interventions
Pregnant women with pregnancy associated iron deficiency anemia and hemoglobin less than or equal 10 gm/dl (8-10 gm/dl) will included in this study after informed consent.
Studied women will receive either heme-bound iron Optifer (HIO) tablets twice daily one tablet morning and one tablet evening according to manufacturer instructions (study group) or Trihmeic 350 mg oral ferrous fumarate once daily according to manufacturer instructions (control group) for at least more than or equal 3 months
Pregnant women with pregnancy associated iron deficiency anemia and hemoglobin less than or equal 10 gm/dl (8-10 gm/dl) will included in this study after informed consent. Studied women will receive either heme-bound iron Optifer (HIO) tablets twice daily one tablet morning and one tablet evening according to manufacturer instructions (study group) or Trihmeic 350 mg oral ferrous fumarate once daily according to manufacturer instructions (control group) for at least more than or equal 3 months for correction of pregnancy associated iron deficiency anemia. 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 anemia using the hemoglobin, ferritin levels, mean corpuscular volume and mean corpuscular hemoglobin. The first half of the participants will receive the Trihmeic 350 mg oral ferrous fumarate then the second half of the participants will receive the heme-bound iron Optifer (HIO) tablets.
Sponsors
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
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 includes; pregnant women more than or equal 20 years old, 14-26 weeks` gestation, with hemoglobin less than or equal 10 gm/dl (8-10 gm/dl) due to iron deficincy anemia. Iron deficiency anemia diagnosed by the following parameters; hemoglobin concentration (gm/dl), serum ferritin (ug/l), mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH).
Exclusion criteria
Pregnant women with anemia other than iron deficiency anemia and/or received blood transfusion during current pregnancy will excluded from this study.
Outcome results
None listed