Efficacy of Iron Bisglycinate in Treatment of Iron Deficiency Anemia in Pregnant Women

Study Overview
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Brief Summary
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Anemia in pregnancy is defined by the World Health Organization as hemoglobin levels of ≤ 11 g/dl. Globally, a prevalence rate of 38% was estimated by the World Health Organization for pregnant women.Treatment of iron deficiency anemia during pregnancy remains a main public health issue. Oral iron salts have been recommended for treatment of iron deficiency anemia e.g. ferrous fumarate. Increasing the dose of ferrous fumarate will subsequently increase the bioavailability of iron preparation, however it also increases the frequency of gastrointestinal tract side effects e.g. nausea, constipation, diarrhea, flatulence, and black stained stools. Besides, the increased bioavailable ferrous fumarate may decrease by many foods and / or chelating drugs in the gastrointestinal tract which interfere with its absorption leading to variability in the hemoglobin correction during the treatment. Ferrous bisglycinate is an iron amino acid chelate. It is formed by reaction of ferrous iron with two molecules of the amino acid glycine by a covalent bound in a process called chelation. Ferrous bisglycinate is claimed to have better patient compliance because of fewer gastrointestinal tract side effects. It is also claimed that ferrous bisglycinate improves iron absorption, storage and increase hemoglobin level better than the conventionally used iron salts.

Official Title
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Iron Bisglycinate Chelate or Ferrous Fumarate in Treatment of Iron Deficiency Anemia in Pregnant Women

Conditions
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Iron Deficiency Anemia of Pregnancy

Intervention / Treatment
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* Drug: Iron bisglycinate Oral Tablet
* Drug: Ferrous Fumarate Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women aged 20 to 40 years, 14-27 gestational weeks calculated from the first day of their last menstrual period and confirmed by ultrasound Singleton fetus hemoglobin level from 7-9.9 g/dL. Exclusion Criteria: All women with high risk pregnancy e.g. hypertension, diabetes multiple pregnancy women with severe anemia (Hb >7 g/dl) anemia due to other causes than iron deficiency as chronic blood loss, hemolytic anemia or thalassemia. women with hepatic, renal or cardiovascular abnormality; women with peptic ulcer, esophagitis, gastritis or hiatus hernia family history of thalassemia, sickle cell anemia, or malabsorption syndrome hypersensitivity to iron preparations or current use of iron supplementation.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Iron bisglycinate (27mg of elemental iron) | Drug: Iron bisglycinate Oral Tablet<br> <br> |
| Active Comparator: Group B<br>Ferrous fumarate (115mg of elemental iron) | Drug: Ferrous Fumarate Oral Tablet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level |  | At 4 weeks |