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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03830034
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Abdel Shafy El Shahawy, 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).

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Amino Acid chelated iron tab 15 mg Drug: Ferrous Fumarate tab 350 mg( 115 mg elemental iron) Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial
Actual Study Start Date : February 2, 2019
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: 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).
Drug: Amino Acid chelated iron tab 15 mg

Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) a dose recommended by the company of the product.

Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption.

Substances that inhibit absorption such as tannins & milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption.

Follow up will be done for all the pregnant women included in our studies at baseline & then 4, 8 & 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed.

Other Name: Ferrotron

Active Comparator: 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.
Drug: Ferrous Fumarate tab 350 mg( 115 mg elemental iron)

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.

Some instructions will be given to all the pregnant women included in our study as follow: Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption.

Substances that inhibit absorption such as tannins & milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption.

Follow up will be done for all the pregnant women included in our studies at baseline & then 4, 8 & 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed.

Other Name: Haemacaps




Primary Outcome Measures :
  1. Hemoglobine (Hb) Rise [ Time Frame: after 12 weeks of treatment. ]
    follow up CBC after 12 weeks of treatment given


Secondary Outcome Measures :
  1. Hemoglobine (Hb) Rise [ Time Frame: after 4,8 weeks of treatment. ]
    Follow up CBC after 4,8 weeks of treatment given

  2. Adverse effects of the medication given [ Time Frame: 3months ]
    constipation, nausea, allergy.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   this trial conducted on treatment of iron deficiency anemia in pregnant women
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830034


Contacts
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Contact: Ahmed Elshahawy, MD +01223266380 ahmedshafy@hotmail.com

Locations
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Egypt
Ain shams university maternity hospital Recruiting
Cairo, Egypt, 25187
Contact: Ahmed A Elshahawy, MD    +201223266380    ahmedshafy@hotmail.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Ahmed Elshahawy, MD Ain Shams University

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Responsible Party: Ahmed Abdel Shafy El Shahawy, lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT03830034    
Other Study ID Numbers: IDA
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Ferrous fumarate
Iron Chelating Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action