Treatment of Iron Deficiency Anemia With Pregnancy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Cairo University
Sponsor:
Information provided by (Responsible Party):
Ghada Abdel Fattah, Cairo University
ClinicalTrials.gov Identifier:
NCT02005588
First received: November 27, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Iron Deficiency Anemia of Pregnancy
Drug: amino acid chelated iron
Drug: iron salt (ferrous fumarate)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between Aminoacid Chelated Iron and Iron Salt in Treatment of Iron Deficiency Anemia With Pregnancy

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • change in hemoglobin level [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the occurence of side effects (abdominal colics, constipation, or metallic taste) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • change in serum ferritin level [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • cost of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: amino acid chelated iron arm
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.
Drug: amino acid chelated iron
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.
Other Name: ferrotron capsules
Drug: iron salt (ferrous fumarate)
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.
Other Name: hemoton capsules
Active Comparator: iron salt arm
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.
Drug: amino acid chelated iron
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.
Other Name: ferrotron capsules
Drug: iron salt (ferrous fumarate)
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.
Other Name: hemoton capsules

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005588

Locations
Egypt
faculty of medicine, Cairo University Not yet recruiting
Cairo, Egypt, 002
Contact: Ghada A Abdel Moety, lecturer    00201006513305    ghadaabdelfatah2007@yahoo.com   
Principal Investigator: Ghada Abdel Fattah Abdel Moety, lecturer         
Sponsors and Collaborators
Cairo University
Investigators
Study Director: Ahmed M Sayed, professor Cairo University
  More Information

No publications provided

Responsible Party: Ghada Abdel Fattah, lecturer of obstetrics and gynecology, faculty of medicine, Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT02005588     History of Changes
Other Study ID Numbers: ferrot2013, nerhado pharmaceutical company
Study First Received: November 27, 2013
Last Updated: December 4, 2013
Health Authority: Egypt: Ministry of Higher Education

Keywords provided by Cairo University:
amino acid chelated iron
iron salt
iron deficiency anemia

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Iron Metabolism Disorders
Anemia
Deficiency Diseases
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Metabolic Diseases
Iron Chelating Agents
Ferrous fumarate
Iron
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014