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Treatment of Iron Deficiency Anemia With Pregnancy

Primary Purpose

Iron Deficiency Anemia of Pregnancy

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
amino acid chelated iron
iron salt (ferrous fumarate)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia of Pregnancy focused on measuring amino acid chelated iron, iron salt, iron deficiency anemia

Eligibility Criteria

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

Inclusion Criteria:

  • Age: 20-40 years
  • Pregnant 14-18 weeks
  • Singleton fetus
  • Hb 7-10.9 g/dl
  • Serum ferritin <12 microgram/L

Exclusion Criteria:

  • history of anemia due to other causes as chronic blood loss, hemolytic anemia or thalassemia
  • Multiple pregnancy
  • known hepatic, renal or cardiovascular abnormality.
  • Known peptic ulcer, esophagitis, gastritis or hiatus hernia.
  • Family history of thalassemia, sickle cell anemia, or malabsorption syndrome.
  • Iron preparation intake within 24 hours of inclusion

Sites / Locations

  • faculty of medicine, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

amino acid chelated iron arm

iron salt arm

Arm Description

this arm will contain 150 pregnant women with proved iron deficiency anemia and pregnant 14-18 weeks. these pregnant women will be given amino acid chelated iron capsules (15 mg iron/capsule) 1-2 capsules daily according to hemoglobin level (hemoglobin 7-9 g/dl will receive 2 capsules, and hemoglobin 9.1-11 g/dl will receive 1 capsule). complete blood picture and serum ferritin will be assessed at 22-23 weeks, 29-30 weeks and 36-37 weeks. possible side effects (colicky abdominal pains, constipation and metallic taste) will be asked about in each follow up visit.

this arm will contain 150 pregnant women with proved iron deficiency anemia and 14-18 weeks gestation. these women will be given oral iron salt ferrous fumarate capsules (350 mg iron/ capsule containing about 70 mg elemental iron/ capsule) 1-2 capsules daily according to hemoglobin level (hemoglobin 7-9 g/dl will receive 2 capsules daily and hemoglobin 9.1-11 g/dl will receive 1 capsule daily. women will be followed up with complete blood picture and serum ferritin at 22-23 weeks, 29-30 weeks and 36-37 weeks. women will be asked about possible side effects (colicky abdominal pains, constipation, and metallic taste) in each visit.

Outcomes

Primary Outcome Measures

change in hemoglobin level

Secondary Outcome Measures

the occurence of side effects (abdominal colics, constipation, or metallic taste)
change in serum ferritin level

Full Information

First Posted
November 27, 2013
Last Updated
July 27, 2015
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02005588
Brief Title
Treatment of Iron Deficiency Anemia With Pregnancy
Official Title
Comparison Between Aminoacid Chelated Iron and Iron Salt in Treatment of Iron Deficiency Anemia With Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Iron deficiency anemia is a very common problem accompanying pregnancy. in this study, the investigators are going to compare the efficacy and tolerability of two preparations of oral iron in treatment of iron deficiency anemia with pregnancy.
Detailed Description
In this study, the investigators are going to compare two preparations of oral iron in treatment of iron deficiency anemia with pregnancy. a total of 300 pregnant women will be randomly divided into two equal groups (each containing 150 pregnant woman). one group will receive amino acid chelated iron and the other group will receive iron salt (ferrous fumarate). All pregnant women attending the obstetrics outpatient clinic of kasr al aini hospital at 14-18 weeks gestation will be submitted to complete blood picture and serum ferritin. those who prove to have iron deficiency anemia (hemoglobin less than 11g/dl and serum ferritin less than 12ug/l) will be included in the study. All eligible women will be followed up at 22-23, 29-30 and 36-37 weeks' gestation for the change in hemoglobin level and ferritin level. all women will be also enquired about different side effects during treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia of Pregnancy
Keywords
amino acid chelated iron, iron salt, iron deficiency anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
amino acid chelated iron arm
Arm Type
Active Comparator
Arm Description
this arm will contain 150 pregnant women with proved iron deficiency anemia and pregnant 14-18 weeks. these pregnant women will be given amino acid chelated iron capsules (15 mg iron/capsule) 1-2 capsules daily according to hemoglobin level (hemoglobin 7-9 g/dl will receive 2 capsules, and hemoglobin 9.1-11 g/dl will receive 1 capsule). complete blood picture and serum ferritin will be assessed at 22-23 weeks, 29-30 weeks and 36-37 weeks. possible side effects (colicky abdominal pains, constipation and metallic taste) will be asked about in each follow up visit.
Arm Title
iron salt arm
Arm Type
Active Comparator
Arm Description
this arm will contain 150 pregnant women with proved iron deficiency anemia and 14-18 weeks gestation. these women will be given oral iron salt ferrous fumarate capsules (350 mg iron/ capsule containing about 70 mg elemental iron/ capsule) 1-2 capsules daily according to hemoglobin level (hemoglobin 7-9 g/dl will receive 2 capsules daily and hemoglobin 9.1-11 g/dl will receive 1 capsule daily. women will be followed up with complete blood picture and serum ferritin at 22-23 weeks, 29-30 weeks and 36-37 weeks. women will be asked about possible side effects (colicky abdominal pains, constipation, and metallic taste) in each visit.
Intervention Type
Drug
Intervention Name(s)
amino acid chelated iron
Other Intervention Name(s)
ferrotron capsules
Intervention Description
the drug will be given to pregnant women 14-18 weeks' gestation who prove to have iron deficiency anemia. the dose will be given according to hemoglobin level. for hemoglobin 7-9 g/dl, 2 capsules will be given daily. for hemoglobin 9.1-11 g/dl, 1 capsule will be given daily. complete blood picture and serum ferritin will be measured at 22-23, 29-30 and 36-37 weeks' gestation.
Intervention Type
Drug
Intervention Name(s)
iron salt (ferrous fumarate)
Other Intervention Name(s)
hemoton capsules
Intervention Description
this drug will be given to pregnant women 14-18 weeks' gestation with iron deficiency anemia. the dose will be given according to hemoglobin level. for hemoglobin 7-9 g/dl, 2 capsules will be given daily, and for hemoglobin 9.1-11 g/dl, 1 capsule will be given daily. complete blood picture and serum ferritin will be measured at 22-23, 29-30 and 36-37 weeks' gestation.
Primary Outcome Measure Information:
Title
change in hemoglobin level
Time Frame
6 months
Secondary Outcome Measure Information:
Title
the occurence of side effects (abdominal colics, constipation, or metallic taste)
Time Frame
6 months
Title
change in serum ferritin level
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
cost of treatment
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 20-40 years Pregnant 14-18 weeks Singleton fetus Hb 7-10.9 g/dl Serum ferritin <12 microgram/L Exclusion Criteria: history of anemia due to other causes as chronic blood loss, hemolytic anemia or thalassemia Multiple pregnancy known hepatic, renal or cardiovascular abnormality. Known peptic ulcer, esophagitis, gastritis or hiatus hernia. Family history of thalassemia, sickle cell anemia, or malabsorption syndrome. Iron preparation intake within 24 hours of inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Sayed, professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
faculty of medicine, Cairo University
City
Cairo
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

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Treatment of Iron Deficiency Anemia With Pregnancy

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