Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial

Phase 4

• Conditions: Iron Deficiency Anemia
• Interventions: Drug: Amino Acid chelated iron tab 15 mg; Drug: Ferrous Fumarate tab 350 mg( 115 mg elemental iron)

• Registration Number: NCT03830034
• Lead Sponsor: Ain Shams University

Brief Summary

Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).

Detailed Description

Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-02
• Study Start: 2019-02-02
• Study First Submitted: 2019-02-02
• Study First Submitted QC: 2019-02-02
• Last Update Submitted: 2019-02-02
• Study First Posted: 2019-02-05
• Last Update Posted: 2019-02-05
• Primary Completion: 2019-10-15
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Pregnant women at 14 -18 weeks of gestation calculated from the first day of their last menstrual period and confirmed or modified by ultrasound
• Hemoglobin level 8-10.5 g/dL
• Serum ferritin<15µg/L

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Exclusion Criteria

• The presence of anemia from causes other than iron deficiency(e.g: Folat deficiency anemia,Vitamin B12 deficiency, ect...).
• Multiple gestations
• The presence of clinical and/or laboratory evidence of hepatic, renal, hematological or cardiovascular disease
• Patients with known gastritis
• History of mal-absorption syndrome
• Those with known hypersensitivity to iron preparations
• Those under current iron supplementation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amino Acid chelated iron tab 15 mg group	Amino Acid chelated iron tab 15 mg	Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) prepared by egyptian pharmaceutical company (nerhadou) once daily (a dose recommended by the company of the product).
Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group	Ferrous Fumarate tab 350 mg( 115 mg elemental iron)	Contain 75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb\<9g/dl) this dose can be doubled as recommended by the company of the product.

Primary Outcome Measures

Name	Time	Method
Hemoglobine (Hb) Rise	after 12 weeks of treatment.	follow up CBC after 12 weeks of treatment given

Secondary Outcome Measures

Name	Time	Method
Hemoglobine (Hb) Rise	after 4,8 weeks of treatment.	Follow up CBC after 4,8 weeks of treatment given
Adverse effects of the medication given	3months	constipation, nausea, allergy.

Trial Locations

Locations (1)

Ain shams university maternity hospital; 🇪🇬 Cairo, Egypt