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

Last updated: February 2, 2019
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

4

Condition

Anemia

Treatment

N/A

Clinical Study ID

NCT03830034
IDA
  • Ages 18-40
  • Female

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant women at 14 -18 weeks of gestation calculated from the first day of theirlast menstrual period and confirmed or modified by ultrasound

  • Hemoglobin level 8-10.5 g/dL

  • Serum ferritin<15µg/L

Exclusion

Exclusion Criteria:

  • The presence of anemia from causes other than iron deficiency(e.g: Folat deficiencyanemia,Vitamin B12 deficiency, ect…).

  • Multiple gestations

  • The presence of clinical and/or laboratory evidence of hepatic, renal, hematologicalor cardiovascular disease

  • Patients with known gastritis

  • History of mal-absorption syndrome

  • Those with known hypersensitivity to iron preparations

  • Those under current iron supplementation

Study Design

Total Participants: 150
Study Start date:
February 02, 2019
Estimated Completion Date:
December 01, 2019

Study 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).

Connect with a study center

  • Ain shams university maternity hospital

    Cairo, 25187
    Egypt

    Active - Recruiting

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