Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Ain Shams University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Hemoglobine (Hb) Rise
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
Amino Acid chelated iron tab 15 mg group
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).
Intervention: Amino Acid chelated iron tab 15 mg (Drug)
Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group
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.
Intervention: Ferrous Fumarate tab 350 mg( 115 mg elemental iron) (Drug)
Outcomes
Primary Outcomes
Hemoglobine (Hb) Rise
Time Frame: after 12 weeks of treatment.
follow up CBC after 12 weeks of treatment given
Secondary Outcomes
- Adverse effects of the medication given(3months)
- Hemoglobine (Hb) Rise(after 4,8 weeks of treatment.)
Investigators
Ahmed Abdel Shafy El Shahawy
lecturer
Ain Shams University