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

Primary Purpose

Iron Deficiency Anemia

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Amino Acid chelated iron tab 15 mg
Ferrous Fumarate tab 350 mg( 115 mg elemental iron)
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ain shams university maternity hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Amino Acid chelated iron tab 15 mg group

Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Hemoglobine (Hb) Rise
follow up CBC after 12 weeks of treatment given

Secondary Outcome Measures

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

Full Information

First Posted
February 2, 2019
Last Updated
February 2, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03830034
Brief Title
Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial
Official Title
Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
October 15, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amino Acid chelated iron tab 15 mg group
Arm Type
Experimental
Arm Description
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).
Arm Title
Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Amino Acid chelated iron tab 15 mg
Other Intervention Name(s)
Ferrotron
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ferrous Fumarate tab 350 mg( 115 mg elemental iron)
Other Intervention Name(s)
Haemacaps
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemoglobine (Hb) Rise
Description
follow up CBC after 12 weeks of treatment given
Time Frame
after 12 weeks of treatment.
Secondary Outcome Measure Information:
Title
Hemoglobine (Hb) Rise
Description
Follow up CBC after 4,8 weeks of treatment given
Time Frame
after 4,8 weeks of treatment.
Title
Adverse effects of the medication given
Description
constipation, nausea, allergy.
Time Frame
3months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
this trial conducted on treatment of iron deficiency anemia in pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Elshahawy, MD
Phone
+01223266380
Email
ahmedshafy@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Elshahawy, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain shams university maternity hospital
City
Cairo
ZIP/Postal Code
25187
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed A Elshahawy, MD
Phone
+201223266380
Email
ahmedshafy@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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